FDA 510K Implant abutment clearance

[TheLabGuy]

I wanted to start a thread on this because the FDA and I suppose the NADL will be posting something official on this in the next week or so. We've all known that the Abutment interfaces obviously need 510K approved via the FDA. I know most of us here don't mill the interfaces but whats about to change is the enforcement of what your making above the interface...i.e. hybrid abutments. I didn't know that the FDA does require a 510K approval on what's above the interface as well. According to what I currently know (and feel free to chime in if you have additional information),that the FDA does a 'fatigue' test on the abutment, which means it does include whats above the interface per the 510K. Therefore, if you're making hybrid abutments in-house, you have to have 510K approval unless...you have a closed system (only two are 510K approved) Sirona, Biodent. Also, that UCLA abutments DO NOT fall under this 510K requirement because they are hand made. Although 3Shape already has the 'fatigue' restrictions/limitations built into the software, Exocad is working on it to what I know now, but this does not mean you are 510K approved. Like I hinted to earlier, this is relatively new information to me, if you know more, please share or if I shared something wrong, please correct me.

 

[JohnWilson]

This will be the most debatable topic for years to come. NADL on the 9th will post their understanding of the law, and what it will take to be compliant.

Milling anything above the interface (via a blank or CAD base) has never been challenged or enforced as far as I know I certainly wonder why this is now becoming an issue today.

I suspect its about money like most things that force change.

 

[2thm8kr]

I suspect its about money like most things that force change.

The implant companies have a stronger lobby and more money to make this happen whether you like it or not.

 

[JKraver]

Custom abutments have definitely eaten into their bottom line.

 

[grantoz]

Will they test the stuff from china etc? you should also lobby to who ever listens that the stuff that isnt fda approved ie from china puts the dentist at risk legally that really makes them nervous .Then just use the fda approved stuff charge more and use fda as a weapon against 3hit where ever it comes from.We all want protection if the rules are even then you can embrace it. the cost of fda is part of business, lobby all the manufacturers ,be transparent about stuff costing what it costs we all worry about increasing costs and how we will break it to the dentists sometimes thing just go up in price so we need to own the problem and use it to our advantage.

 

[rkm rdt]

Does it say anything about repressing used emax for hybrids?

 

[Tom Moore]

Will they test the stuff from china etc? you should also lobby to who ever listens that the stuff that isnt fda approved ie from china puts the dentist at risk legally that really makes them nervous .Then just use the fda approved stuff charge more and use fda as a weapon against 3hit where ever it comes from.We all want protection if the rules are even then you can embrace it. the cost of fda is part of business, lobby all the manufacturers ,be transparent about stuff costing what it costs we all worry about increasing costs and how we will break it to the dentists sometimes thing just go up in price so we need to own the problem and use it to our advantage.

The labs in China that import to the US are already FDA registered and will have no problem chinning to any bar set for domestic labs.

This is about the implant companies using their financial strength to keep as many of us out of this market as possible.

Join the NADL and be part of the voice to force the FDA to make this clear to everyone.

 

[2thm8kr]

The labs in China that import to the US are already FDA registered and will have no problem chinning to any bar set for domestic labs.

This is about the implant companies using their financial strength to keep as many of us out of this market as possible.

Join the NADL and be part of the voice to force the FDA to make this clear to everyone.

Do you have any information on what the NADL is doing about this now?

 

[Gru]

I'm confused. How is joining the NADL going to help anything besides receiving timely information?

 

[RJS8669]

One interesting facet of this is that a licensed dentist can still prescribe something that is not FDA-compliant, if based on experience, the prescribed solution works. In other words, a doctor can write a prescription for a hybrid abutment or a screw-retained FCZ using a Ti insert and the laboratory can legally fill that prescription. The lab may not, however, advertise such restorations.

Go figure...

 

[doug]

It is my hope that in the overall solution the surgeons are held to a higher standard of patient care by being , finally, forced to provide appropriate treatment to the patients at the outset of treatment by using guided surgery to insure that implant placement is done to prevent the need to have the abutment angulation outside an acceptable limit. I can dream, can't I? Again, [email protected] for any question that you would like addressed in the future by the NADL. He is a tremendous resource and one of the best reasons to be an NADL member.

 

[Calvin Song]

The implant companies have a stronger lobby and more money to make this happen whether you like it or not.

The common misconception is just that. There are no abutment blanks that are FDA cleared to be distributed in the US market to use as the CAD/CAM Customized Abutment. The abutment blanks are cleared for that facility alone, and not to be used by anyone else. Different labs have different systems and equipment. 510k clearance from the FDA for Customized Abutments are as a package, but just one part. Only exception here is the Sirona systems. If you use the Sirona Blanks, machines, and software you don't have to obtain the 510k (Sirona CAD/CAM System K111421).

This is further explanation on the whole 510(k) issue:

Are you purchasing ILLEGAL abutments?

As of November 2015, 14 dental milling centers and CAD/CAM titanium abutment blank suppliers (including some milling machine companies) are being investigated by the FDA for illegal abutment milling and distribution.

CAD/CAM customized abutments are classified as Medical Devices Level 2 by the FDA. In order to mill CAD/CAM customized abutments, the facility must have 510(k) clearance from the FDA or it is ILLEGAL (with the exception of authorized milling centers using all systems and materials from Sirona). Most of these illegal activities are done intentionally for personal gain with no regards for the law.

Some illegal blank suppliers insist their products are FDA pending but, pre-marketing the CAD/CAM customized abutments before obtaining full 510(k) clearance is also ILLEGAL. Pending does not mean they are approved.

A common fallacy is that any lab can mill the CAD/CAM customized abutments as long as the titanium abutment blanks are FDA approved. From this many companies insist they are distributing FDA approved blanks. At present time, there are no blanks by itself that are 510(k) cleared to mill as CAD/CAM customized abutments. Since, the abutments becomes a medical device level 2 when using CAD/CAM technology to manufacture, the facility must acquire 510k clearance from the FDA. Only way to be exempt from the FDA regulation is to hand mill the abutments.

The reason the FDA have these regulations in the dental industry is to ensure the safety, efficacy and security of medical devices that are produced and marketed in the US. By having 510(k) clearance, the general public will trust our products when purchased. To produce medical devices level 1, 2 or 3, one must follow these rules and guidelines because it is the LAW. One should never support or enable these illegal activities.

By having 510(k) clearance in place, the manufacturer will minimize faulty production. Also, if anything goes wrong with these devices, manufacturers can locate where they came from and resolve the issues in a systematic manner. This essential process is an additional cost factor for having 510(k) clearance. The FDA has requested any illegal activities be reported directly to them. Please report illegal abutment production to:

Surveillance and Enforcement Branch II
FDA/CDRH/OC/DPLC
Building 66,
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

 

[rkm rdt]

 

[PearlZ]

prepare your collective buttholes.

buy sirona or never make another abutment.

ha ha ha ha ha ha ha *cough*

thanks, i havent laughed that hard since i was a little girl.

 

[rkm rdt]

Of course they can send them to some backwater 3rd world country like Canada or Vermont.

 

[PearlZ]

Of course they can send them to some backwater 3rd world country like Canada or Vermont.

while that might be an avenue to countermand the lab'd necessity for a 510k, any medical device sold in or TO the usa needs the 510k. which means china needs them, canada, even canada2: vermont, and canada3: the search for canada2.

all to say every lab now needs to pay sirona 110k USD. however i am quite sure there wouldnt be any way they'd check if it was even part of production.

so pay up; use it or don't, but pay up.

lol

ri-goddamn-diculous.

 

[vurban210]

The words in the post seem to be written in such a way that one would perceive they are from the FDA. In fact, they are not. This has been copied from another dental labs website. Not saying Calvin Song wrote it, but the lab that did is asking you to turn in your colleagues for "illegal abutment manufacturing".

http://creodental.com/are-you-purchasing-illegal-abutments/

Edited to add: This is really sad. One would think that if you were aware of another dental lab doing something unethical you would approach them directly to let them know. But nope, because you can "submit to [email protected]. The reported facilities will be submitted to the proper authorities at the FDA." Who needs enemies when you have friends like this?

 

[2thm8kr]

Edited to add: This is really sad. One would think that if you were aware of another dental lab doing something unethical you would approach them directly to let them know. But nope, because you can "submit to [email protected]. The reported facilities will be submitted to the proper authorities at the FDA." Who needs enemies when you have friends like this?

If you are the type to 'turn someone in' for making a legitimate income, you should be punched in the face until rendered unconscious.

Calvin, nice try with the scare tactics.

 

[vurban210]

If you are the type to 'turn someone in' for making a legitimate income, you should be punched in the face until rendered unconscious.

Calvin, nice try with the scare tactics.

How much you wanna bet he just happens to be rocking a Sirona system?

And didn't you leave out ".....until you are rendered unconscious and then fed to a hungry pack of wolves."?

 

[2thm8kr]

And didn't you leave out ".....until you are rendered unconscious and then fed to a hungry pack of wolves."?

I doubt wolves would find those types palatable.