Hi, U have answered yourself. Plz proceed according to the ISO guidelines.

ISO 9000 standards are important in the European Community and perhaps in other parts the world also. In the United States it is the FDA that decides to which standards any device must be tested.

The interesting part is that since dental implants have been available, which was probably in the 1950s, the FDA has categorized dental implants as class III medical devices but it has never, I have to stress this, never has it actually been called for. So right now in the United States a class III medical device in the form of a dental implant is still evaluated relative to safety and effectiveness as shown in the 510 K premarket notification rather than the far more stringent premarket approval.

This is sometimes a little hard to believe. We have standards that are quite meticulous but the FDA has not required the dental implants follow those guidelines or have to achieve the guidelines of the premarket approval. Premarket notification is primarily a paper trail. The FDA may require some information regarding clinical performance but they do not necessarily require this of everyone. In essence it becomes a little bit of a guessing game as to what they will require for a new implant.

I wrote the following reference number of years ago. Interestingly, at that time, the American dental Association had, and still has, a program where it "Accepts" specific Dental materials.

Eckert, S. E. (1995). "Food and Drug Administration requirements for dental implants." J Prosthet Dent 74(2): 162-168.

The Food and Drug Administration (FDA) is a section of the Department of Health and Human Services of the United States Government, and its primary responsibility is to control the distribution of food, drugs, and medical devices within the country while ensuring public safety. The sale and distribution of dental implants is under the regulatory control of the FDA. Device classification, procedures for approval, and the current status of the approval process for endosseous implants are described in this article. The premarket approval procedure of the FDA is compared with the American Dental Association certification process. Issues related to the safety and effectiveness of dental implants are discussed.

The ADA used to have a set of guidelines that they applied to dental implants and those guidelines were quite similar to what the class III medical device was had the FDA ever called for the class III medical device. Remember the FDA had the criteria but never required that dental implants be held to that set of criteria. So back in the late 1980s and early 90s there were a few different companies that didn't go through the ADA acceptance program and were accepted by the American dental Association. The exact number of implants or implant systems that were accepted is hard to put your finger on. The reality was that gaining acceptance was not in easy process. Maintaining that you had gained that acceptance was either a three year time frame which provided a provisional acceptance or a five-year documentation timeframe which identified full acceptance. Then once you hit hit that five year mark you just had to not change your implant design fundamentally and it required a payment each year. I don't know what the payment was and I don't know how they determine fundamental changes to the implants but what I can tell you is that today if you go to the ADA accepted pages and you search for dental implants you will find no dental implants that have been accepted by the American dental Association.

So whatever the FDA has mandated, the mandate is sort of a strange requirement because it is indeed required if the FDA ever calls for fulfillment of that requirement within the guidelines of the premarket approval which is the more stringent approval process for class III medical devices.

There was a point where the FDA decided to look at this question. The FDA advisory panel made the suggestion that coated implants be evaluated at the class III level and that uncoated implants be evaluated at class II levels. I'm not sure what happened with that recommendation because it was about that time that hydroxyapatite coated implants started to drop out of the marketplace. Indeed there were some problems with some hydroxyapatite coded implants whereby the bond to the underlying implant material weakened over time and this led to what we would probably describe today as periimplantitis. So the hydroxyapatite coating would break up and it would create foreign body reactions that eventually cause infections around the implants.

Please realize that these statements are from decades ago and we are depending upon my memory of how things went. I think it's pretty good, my memory, but it may not be perfect. What we do know today is that there are implants in the marketplace and implants that are coming to the market that have a very thin coating on them. The very thin coating does not seem to cause the FDA any heartache. We are talking about coatings in the levels of nano meters rather than micrometers which was the case with the previous generation of hydroxyapatite. Will the exceedingly thin hydroxyapatite coating survive better? We don't know the answer to this because hydroxyapatite was a material that seem to fail after 7 to 10 years and of course it did not fail for every implant but it did seem to be at a higher rate than what you would see with machined or machined and roughened implants that are used more frequently today.

It's an interesting history lesson. The thing about it that always has been a concern for me is that the Food and Drug Administration's primary responsibility to the public is in the form of protection. When a new implant comes in the market with a premarket notification rather than a premarket approval they have moved down the protection list rather than up the protection list. by that I mean that the premarket approval is a far more stringent requirement than the premarket notification.

The ISO 9000 series of assessments, which have no influence on the American market, seemed to be good and stringent requirements.

Look for FDA guidelines on dental implants or follow scientific literature of similar devices in the market.

All FDA does is to allow marketing of food, drugs, devices based upon safety and efficacy. If a device is to be sold in the United States then it must have FDA clearance to do so. FDA does not test, It does not approve, it evaluates data, I guess that's easiest way to say it. So asking what must be done to allow a medical device to be "approved" does not demonstrate a clear understanding of what the FDA does and does not do.

A person who has "invented" a specific device can start using it in the treatment of their patients whenever they want to as long as they are willing to accept the medical legal risk. They can give it to their friends and their friends can use it to treat patients, pay they could give it to their enemies and their enemies could use it to treat patients too but that's old different story. The problem comes when there is a commercial use of a device. For all intents and purposes it has to be across state lines because it fits within this particular state it still comes down to individual states rights and the individual states can make decisions regarding the use or nonuse of a device within their own state.

What market are you referring to?

If in the EU, the former MDD, and now the new Medical Device Regulations (MDR) state sufficient clinical evidence must be provided commensurate with the risks of the device. Integral to this aim is having a very clear and robust Risk Management process. This would involve of course having an intimate understanding of the use, benefits and risks associated with the device from various resources (eg, background education, literature, user discussions, adverse event analysis, etc.). If a clinical investigation is deemed appropriate, then you should be sure it addresses the risk and supports the claims of intended use.

You should hire a consultant if you are uncertain about this.