FDA on Mini Implants

Dennis, a dentist, asks:

In all of the discussions on mini dental implants, there have been several references to the FDA requirement of a dental implant diameter of at least 3mm (formerly 3.25mm) and length of 7mm to qualify for the description of a dental implant.

1. When were these guidelines established? Does anybody have any reference material for this?

2. How does this ‘classification’ affect the insurance payments
(where allowable) of dental implants of either smaller diameter, such as mini
dental implants or shorter length, such as when Endopore and Bicon dental implants
are used?

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28 thoughts on “FDA on Mini Implants

  1. Dennis,

    I would contact Nobel Biocare.

    They have a 3mm implant advertised as FDA approved.

    It has been on the market for 2 years?

    There is another blog because there is some bad press regarding nobel direct but the implant is working.

    Please let us know what they say.

  2. Just because an implant is FDA approved does not mean it can be used for all cases. This the problem. Know exactly for and how the implant is FDA approved. Sometime the information is not provided to the user by the implant company. I found it it best to contact the FDA. They have been very helpful. They have been helpful in solving some of the problems.

  3. IN DIRECT DISCUSSION WITH FDA THEY IMPLIED THAT TWO MINI IMPLANTS HAVE TO BE USED WITH EACH CEMENTED CROWN.SOME MINI’S ARE FDA APPROVED (OTHER THAN NOBEL) BUT TO MY KNOWLEDGE NONE ARE APPROVED BY ADA.SOME MINI’S HAVE GREATER THAN 10 YR HISTORY WITH SUCCESS. THE QUESTION IS HOW YOU CAN LOAD MINI’S( DECREASED SURFACE AREA)IMMEDIATELY VERSES STANDARD IMPLANTS WITH SUCCESS ESPECIALLY SINCE EVEN WITH STRAUMAN’S SLACTIVE IT TAKES 3-4 WEEKS. STABILIZATION VERSES OSSEOINTEGRATION(ANKYLOSIS).

  4. I think Dr. Callan’s point is very informative. In some cases the FDA approval for a an implant is narrowly defined. For example, the FDA approval may be for immediate loading for single teeth in the mandible. The company rep will state they have FDA approval for immediate loading which is a far broader indication than they have been given. Marketing should not replace research as the primary source of information in implant dentistry.

  5. A well known one piece small dental dental implant or mini dental implant as some wants to call it is called “self-tapping threaded screws indicated for long-term intra-bony applications. Additionally, they ….. may also be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial edentulism, and employing minimally invasive surgical intervention.”

    The quotation is taken clean from the FDA K031106 certification. Note that the term used is “self-tapping titanium threaded screws” and not “implants”. It seems that the FDA has to date decided that any threaded titanium screw that is of diameter 3mm and more is called an implant but anything below that is called a titanium threaded screw. However, its uses appear to be close to, if not equivalent to the uses of conventional implants……….i.e.long-term fixation of new and existing crown and bridge installations. Additional uses are inter-radicular transitional applications, immediate splinting stability, full and partial edentulism…..and using minimally invasive surgical intervention to boot! So the one piece small dental implants, though not labelled as implants seem to be approved to function as implants and is more versatile in that it can be used for a number of uses in which the conventional cannot be used, probably because of size and invasiveness.

    Sounds to me like a prelude to being bestowed the title of I…..t by the king in the not too distant future. And rightly so because the FDA as a responsible and necessarily a cautious and conservative body will take its time and watch and wait and act when the time is ripe.

  6. Interesting to label these minis as screws instead of implants.

    What about the short designs of Endopore and Bicon mentioned? Would they be considered implants as they are shorter than 7mm? May be they are truncated root-forms?

    Looking at the long and short of implants, where do they put the zygomatic implant then? It is definitely not root-form.

  7. I have heard one major internationally prominent lecturer at a major international meeting assert that mini-implants can be permanent and that they can support bridges, dentures and stand alone single crowns. He viewed mini-implants as the implant solution when bone width was inadequate for wider implants.
    I am so confused after reading these comments. Are mini-implants a reasonable and predictable alternative to the implants wider than 3mm? Are imlants narrower tha 3mm implants or screws??

  8. i cant understand how can it be that a mini that is at least 1 mm narrower to a regular implant is such an indication for immediate loading.I mean it is smaller narrower, yet more stable???an anyone help me here?

  9. Implant surface area. From basic math, which I used to teach in a long ago time, surface area = pi(3.14168) X diameter X height. Not complicated. So a conventional implant at say 4mm diameter and 10mm height has a surface area of 126 sq mm. An Imtec mini implant Max has a diameter of 2.4mm, so a 10mm height mini has a surface area of 75 sq mm. Obviously two Imtec Max implants have a surface area of 150 sq mm, more than the single 4mm conventional. When I place multiple units, I use one Imtec per tooth for anteriors and bicuspids and two per tooth for molars, and I use the longest implant I have bone for, usually at least 13mm, often 15mm, and sometimes 18mm. A standard upper “round house” using the “all on 6” method, if we assume we use 4mm standard implants with two 15mm, two 13mm, and two 10mm would have a total of 904 sq mm of surface area. Using the Imtec Max 2.4mm diameter implant, I would use two 18mm in the cuspid area, four 15mm in the anterior area, two 13mm in the 1st bicuspid area (approximately), and two 10mm as I approach the sinus area on the distal. That is a total surface area of 1070 sq mm – more than the six conventional implants. This is not to say the minis are necessarily better than the conventionals, simply that the surface area objection may not apply. Do the simple math for your own combinations, and see what you get.

  10. Reply to Xe: Doesn’t seem that confusing. Standard implant, remove bone permanently from a 4mm hole, place implant, you don’t have that much bone left for support, so you better wait for osseointegration/ankylosis. Mini implant, remove almost no bone (just a 1.2mm pilot hole around 3 to 5 mm deep, thread in the implant (“screw” to you purists out there!) and almost no bone is lost, you have immediate stability from the threads in the bone. Tap it and see. Tap it again in 3 months, 6 months, and you will see that they stay stable. Ten year recalls can be done by Dr. Sendex and other pioneers in this field, and I assume they can still hear that nice solid ringing sound from taping a nicely integrated mini. Less bone lost, almost no long-term consequences if a mini fails as opposed to bone reconstruction if a standard implant fails, I cannot see why more general dentists like myself are not at least considering Dr. Christiansen’s advice and trying mini implants.

  11. Dr Clifford has figured it out! Everyone else seems to be all over the map with their recomendations and directives. Someday the MINI VS. STANDARD war will be over and we will be able to focus on what is truly important. ie. Matching the best implant to the available site, keeping in mind the patients general health, dental health, bruxism habits, # of remaining teeth, financial status etc.

    Surface area is the most important consideration in my book. If bone is narrow and deep, use a narrow and long implant. Wide and shallow bone….. use a wide and short implant. Simple!
    When placed in a healthy patient, they all integrate sooner or later, all other factors being equal.

    This is my experience having placed hundreds of both small and large diameter imps. But I only place so called “immediate load implants”. Sometimes I do so, other times I wait 2 to 12 weeks before loading depending on the other factors. Smokers for example, I’ll wait the longest B4 placing the definitive crown.

    On long span bridges I’ll mix standard immediate load with mini immediate load as the anatomy of the bone changes as you go around the curve. It’s not that hard to figure out!

    Failures , that we only care to wisper about under our breath… if we admit at all, have always been and will continue to be a part of practicing dentistry. Fillings fail, endos fail, bridges fail, and implants fail. Lawyers have taught us,some the hard way, never to use the word “perminant” when talking to patients. Our job is to minimise the redos with treatment planning and common sense. The ones that do that the best, will have the best implant success rate.

    By the way…a failure is only an “opportunity” to do a better proceedure the second time. Some of my best and most satisfying implant cases are “redos”. They can be managed , without patient resentment, if you prepare them properly during treatment planning. If you do “high risk” cases you have to tell them in advance and then they usually work with you if a redo is necessary. Planning is the key, again!
    Dr Tedesco

  12. Surface area is certainly part of the story. More importantly is that the protocol is followed for the placement of the MDI. In my discussions with Dr. Sendax the most important element to the success of the MDI is a pilot hole that only extends just through the cortical bone. This allows the Mini to make its own path through the medullary bone and increases immediate stability. I have began using a diamond bur with a high speed to perforate the cortical bone and no further pilot hole. This works particularly well in the maxillary arch.

    As far as FDA approval, the “long-term” use does require splinting of 2 or more MDI’s or an MDI and a tooth. A rest tab can be used if you want to use only one MDI.

  13. Dr Oppenheimer

    You have suggested “splinting an MDI and a tooth” are you saying that implants should be splinted to natural teeth?

  14. The comments above by Dr. Ben Oppenheimer re: FDA approval are not accurate. The FDA has accepted the MDL mini implant system as “Indicated for Long Term Intra Bony use”. It does not specify that they need to be splinted to natural teeth or other implants. The F.I.R.S.T. Technique that I developed and patented can be used for single tooth replacement with one or more mini implants. This has been used for the past 4 years with better then 98% success. Dr. Ben Knows this but he is choosing to state different facts because he and I are no longer working together and he is not authorized to use my patented process. Please take his comments with caution. As for the splinting to natural teeth, in general it is better to keep the mini’s free from natural teeth however, we do splint to natural teeth if needed depending on the individual case. I have personally not seen many problems doing this clinically. We often will splint multiple mini’s together for a roundhouse or multi unit restoration but also replace single teeth every day with great success (better then 98% over the past 6 years). If anyone would like a copy of my 5 1/2 year clinical study email me and I’ll send it to you. I am now using the MDL which is a stronger mini implant then the 1.8mm mini. The MDL is available in 2.0 and 2.5mm and the MILO is a 3.0mm. Thanks and Happy Holidays!

  15. What I love in these forums is the level of discussion and calibur of contributors

    However I would like to add to this forum that there is no doubt the Mini are here to stay
    We MUST bear in mind that there are one or two limitations with the FIXED cases
    1) Emergence profile is simply not going to happen
    We are going to create an “apple on a stick” type of restoration
    Where we have a forgiving smile line its OK few patients will mind as they got the Implant for a much better price anyway and you dont see it
    2)Minis in my view should be standard of care for lower incisors and upper laterals
    3)When used for larger teeth BIOMECHANICAL design is absolutely imperative
    Small occlusal table ,low cuspal inclination /proper design of occlusion ,long implants ,engaging cortical plates whereever possible ,strict adherence to protocols ,tripodisation (internal as well as external)splinting implants together,cross arch stabilisation etc etc
    4)careful consideration of splinting to teeth ..only under strict guidlines..there is a lot to expand on Todd Shatkins statement of splinting to to teeth and to answer John DDS
    The above applies to standard implants to a lessor extent

    Do not make the mistake of thinking that Minis are easier …they work well but you need to really get the details right where standards can often be more forgiving
    Happy Holidays to all!

  16. I believe that it is very important for OsseoNew’s readers to be accurately informed when it comes to Mini Dental Implants. Dr Todd Shatkin and his father are distributors of the Intra-Lock MDL dental implants and are treatment planning Intra-Lock MDL implants through their Shatkin First Labs for cases with long term crown and bridge treatment on Intra-Lock MDL implants. The Intra-Lock MDL system recently gained approval for market from the FDA for long term intra bony implantation for Maxillary and Mandibular denture stabilization only. They are not approved as he has stated in his interview for long term crown and bridge work. This recommendation puts doctors at a great deal of medical legal risk if they chose to unknowingly utilize an Intra-Lock MDL dental implant “off label”. To my knowledge the IMTEC Sendax MDI is the only mini dental implant with long term crown and bridge approval. The IMTEC Sendax MDI has over 20 years of clinical data on the patented insertion protocol and is the standard that all other mini dental implants are measured against. Anyone can search the FDA 510K database online for this information but I am providing it here verbatim:

    Intended Use: Mini Drive-Lock TM Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock TM Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

  17. John DDS
    WOW what a case !
    But why are you hanging on the lower incisors ?
    There must come a time when you throw in the towel?
    Or am I not seeing the final xray (which would be intresting)
    What long term expectation does the patient have
    Why not remove incisors and place 3 or 4 minis
    It still stays economical but much more
    predictable ?
    If this is working for you I am very impressed
    Dr SS

  18. Dr. Shatkin,
    Your success rates using the IMTEC MDI implants were well documented and during the gathering of clinical data for your study, the two of us had many conversations discussing pro and cons using IMTEC MDI implants for crown and bridge applications. Our conversations always ended with the conclusion that high success rates for crown and bridge were always possible as long as proper protocols and proper patient selection were used. I personally was very appreciative of the time and effort you contributed to complete and publish the 2500+ implant study in Compendium. Please share with the group how difficult it is for any company to provide credible clinical history for the MDI system (mini dental implants as defined by the FDA – “implants smaller than 3.0mm”) whereas the FDA will add the specific language “long-term for crown and bridge applications” to a submitted 510k. Many of our discussions revolved around the risk a clinician faced if he used a product that did not have this specific language and he experienced a failed implant or worse a failed case. This was one discussion that you and I were both in agreement just last year, but it is apparent you have changed your position concerning any malpractice risk using a system not approved for “long-term for crown and bridge applications”. Please advise why you do not find this risky anymore.

    Stephen Hadwin
    EVP – IMTEC Corporation

  19. John DDS
    WOW what a case !
    But why are you hanging on the lower incisors ?
    There must come a time when you throw in the towel?
    Or am I not seeing the final xray (which would be interesting)
    What long term expectation does the patient have
    Why not remove incisors and place 3 or 4 minis
    It still stays economical but much more
    predictable ?
    If this is working for you I am very impressed
    Dr SS

    Thank you for noticing hopefully my reply here will not be deleted as it has been deleted on the original thread 3 times.

    I understand your concern for not too long ago I would have said the same thing. But, my thinking has changed after using the Periolase for 2 years now. If you would like to understand my thinking see

    http://ddsgadget.com/implantcases/?cat=79
    Always with the patients best interest in mind.

    John McAllister

  20. Just love the way all you snipers are going after Dr. Shatkin now. Many of us know and agree with his reasons for leaving Imtec. Those of us who have tried both Imtec and Mini Drive Lock implants know they are essentially identical. Your tool set fits their tool set, diameters are slightly different, but any functional difference is indiscernable. Personally I prefer the looks, feel, and sizing of the MDL implant. The 11.5mm length is especially useful to avoid sinus and mental foramen issues. Do you really think that a failed implant will normally result in a lawsuit that cannot be defended because of FDA wording?Those of us who don’t work for either company just go with the flow and with what works. I have a stock of both brands in my office, and use whatever seems appropriate. Why don’t you use your energy for the good of dentistry and try to help us find a really good system for doing fixed crown and bridge on mini implants without worrying about your patents and your egos? Patients, not patents, are what matters to those of us trying to do the right thing, at a price real people can afford.

  21. Ken…I appreciate your position. Very simply put, using medical devices in an ‘off label’ manner puts you at potential risk. I can see the lawyers now salivating in preparation for cross examination of a dentist, preparing to quote from the FDA documents in open court. It doesn’t look pretty. My intent here is to inform and educate on the facts and provide another voice on the topic. You can be sure that high quality companies like IMTEC are working hard toward your above mentioned wishes. Keep up the good work!

  22. Yes my father owns and operates Samuel Shatkin FIRST, LLC Lab which does provide the same consulting services that he has provided for hundreds of dentists throughout the world over the past 4 years. He provides this service for dentists using any approved mini implant system on the market and not limited to one system. He is also a distributor of the Intra-Lock MDL system which is FDA approved for “Intra-bony Long Term Applications” and in addition has FDA Long Term acceptance for supporting Maxillary and Mandibular Dentures. Stephen Hadwin and Ben Oppenheimer and others are now hired by IMTEC, MDL is their competitor. I think it is important for readers to take all of this with a grain of salt as there is ongoing litigation between the parties.

    Ken thank you for sticking up for me I appreciate your kind words. I wish we could just focus on what is best for our patients also. I continue to practice full time in my Amherst, NY practice and I feel I am offering my patients the best mini implant system presently on the market. I have placed nearly 6000 mini implants over the past 7 years. I can tell you that from my experience the MDL seems to be stronger. I can also tell you that independent studies have also demonstrated the increased strength of the MDL when compared to a 1.8mm mini implant. I have been told that the reason for the increase in strength has to do with the design and the size of the implant. I believe this to be true. Ken I wish you all the best for a successful and happy 2008!

  23. i lost my lower teeth over three years ago,and
    have been to many many dentist who most don’t
    know the first thing about mini implants much less how to make a denture. i can not tell you how much my life has changed since this has
    happened to me. i have already had three surgeries
    and have had artifical bone put in but the dentist i went to have now said i need a bone graft from my hip. i can not afford twenty to thiry thousand dollars for this plus the recovery time i would probably lose my job. i have been
    treated so badly by some of the dentist i have
    been to that i hope i never have to experence that kind of treatment again. i have now had so
    much of my lower gum cut down that wearing a denture is impossible. i work for fifteen doctors and the embrasement and humiliation i have went through the last three years have been almost unbearable, i can’t laugh
    anymore or even smile showing my teeth. surely there is someone out there that can give me a
    little hope that something can be done without
    costing me an arm and a leg.i have been turned down by my insurance even with two letters of medical necessity for they are saying this is cosmetic, this is now effecting my health. please is there a dentist out there that can help me.

    thank you,patricia

  24. Dear Patricia,
    If you have xrays and records of your mouth and would like my opinion on how to treat it I would be happy to help you. I am sure there is a solution for you that will be cost effective and work well for your needs. I can be contacted by phone at 716-839-1700 ext.112.
    Thanks,
    Todd Shatkin, DDS

  25. Dear JohnDDS,

    A most impressive case showing how a mini can be used to rescue severely compromised periodontally involved teeth. I notice that the bone “grew” up the sides of the mini implant by at least 3-4mm, besides stimulating/enabling the regeneration of bone around the adjacent “floating” incisor that was totally lost before.

    This is a definite improvement over the original acceptance of up to 1mm bone loss per year.
    Currently, no bone loss is the standard.

    But what you have shown should become the new standard where lost bone is restored just by placing an implant without any graft! I have never seen this happening in my/other’s conventional cases.

    However, I have several mini implant cases that show phenomenal regeneration of bone that was lost due to periodontal disease. This happened after extraction and immediate placement of a mini implant into the socket with stabilisation. Several of my colleagues have similar experiences.

    Black’s original principle of “Conservation of sound tooth structure” is still relevant today in the era of the dental implant.

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