DAMAS, GMP Study Club in FaceBook

Mark Jackson

Mark Jackson

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You may or may not have heard that the FDA had a meeting recently, in which they debated upon the classification of implant abutments, bars and surgical guides. They are widely considered a Class I medical device, but are considering changing them to a Class II device, in which case, it would be ILLEGAL to make a Custom Abutment unless your lab is fully GMP compliant, registered with the FDA, and can meet the more stringent Class II requirements.

Not good news, but even an even more important reason to get your lab in compliance NOW! You've had since 2003 to do it, why keep putting it off?

Elizabeth Curren and I started a Facebook Group for this very purpose. We invite those interested to join us there. We even hope to get some Rugulatory people to join us.

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Alistar

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Mark,

If they do mandate them as Class II devices, wouldn't that REQUIRE the FDA to inspect those labs on a yearly basis? And what about dental groups that have have their own in house implant manufacturing? Are they going to personally inspect all of them too?

Does the FDA really have the man power and resources to inspect all the labs and dental offices filling implant Rx's?

Wouldn't this only affect "milling" labs, or would this affect those that do a digital design and then outsource the milling?

Are we seeing rampant failure in implant abutments because the labs fabricating them aren't following GMP's? If so, I guess I just haven't heard the public or professional out cry for more regulations in the manufacturing.

What is the main goal of this new classification? Is it to improve patient care? If so, I think that the powers that be are barking up the wrong tree. They should be requiring the doctors and tech's that design implant abutments to get more education and certification on implant placement, design, and seating.

I only say this because of what I've seen the last 2-3 years with the increase in implant placement.

Out of the couple hundred custom abutments that have gone though our lab in the last 2-3 years, 90% or more of the failures were from docs not torquing the abutment down correctly!

The docs are the ones sucking it up in the implant area, and we are the ones stuck dealing with their crap all the time!

Were do we go from here? My question would be...blatantly; how do you fix stupid? You can't regulate "no idiot dentists are allowed to place an implant" so we are going to get stuck with more useless regs. Nice.

I'm not venting this directly at you Mark. I'm just thinking out loud, and trying to make sense of this.
 
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Mark Jackson

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I'm not venting this directly at you Mark. I'm just thinking out loud, and trying to make sense of this.

It's cool, I did the same thing. I was at a meeting for something else, and they dropped this bomb on us. I guess they had some of the big implant abutment manufacturers there, and they would LIKE to see this controlled. I was not allowed to know who was there, but think about who might benefit?

Every implant compnay makes custom abutments, and they lose sales every time one gets made by a lab, and not sent to them. Since they already comply, they would love to shut the labs down from making custom abutments, and it would be an easy sell to the FDA because they consider it part of their implant system, and can cause failures if done wrong..................and believe me, they can show tons of cases done wrong.
 
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Alistar

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It's funny that they put this little meeting together with the FDA just as Ivoclar previews their new e.Max implant abutment solution. Which would would make it really easy and profitable for small to midsize labs to press their own custom abutments.

Not that the e.Max abutments would work for every indication, especially the posterior, but it's a promising alternative for greater customization in the anterior.
 
JohnWilson

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You may or may not have heard that the FDA had a meeting recently, in which they debated upon the classification of implant abutments, bars and surgical guides. They are widely considered a Class I medical device, but are considering changing them to a Class II device, in which case, it would be ILLEGAL to make a Custom Abutment unless your lab is fully GMP compliant, registered with the FDA, and can meet the more stringent Class II requirements.

Not good news, but even an even more important reason to get your lab in compliance NOW! You've had since 2003 to do it, why keep putting it off?

Elizabeth Curren and I started a Facebook Group for this very purpose. We invite those interested to join us there. We even hope to get some Rugulatory people to join us.

Welcome to Facebook - Log In, Sign Up or Learn More

Glad you guys started a group, I just requested to join.

I never saw value in getting my lab certified as I always felt I was working way above board. Tracking and having the paperwork to support what I already know is just a smart thing. I am working toward this now

As it relates to the FDA and reclassifying like any law its teeth is directly related to the money allocated to enforce the law.

Like you said its pretty obvious who is behind this, what doesn't make sense to me is the guys that are cutting the most profit from these individuals will have their GMP's in line. Its the small labs that do far fewer cases that will be the ones that are not in compliance.
 
DMC

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Fine. I'll ch3ck it out as well.

I use good materials, real trained techs, and premium equpiment in a Medical Facility. I do any testing with MCV and my family. (Three Dentists in family and one was professor in C&B) Have nothing to hide. I'm going to make them either way.

(Stupid paperwork...)
 
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Mark Jackson

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It's funny that they put this little meeting together with the FDA just as Ivoclar previews their new e.Max implant abutment solution.

I would hate to own a "MILLING CENTER" today. I hear there is a pressable zirconia coming out too which could really hurt the guys who do nothing but mill for other labs. You just KNOW that the manufacturers want to keep the small labs who can't get the expensive equipment in business.

I was looking at the new LMT today, and you may remember a day when the back pages were all full of milling centers. Now, the main one I see is Aurident...a gold supplier.

Things are getting exciting
 
DMC

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I am buying more mills.

Will you sell me one of yours Mark?

Go play with your press?
 
Mark Jackson

Mark Jackson

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I am buying more mills.

Will you sell me one of yours Mark?

Go play with your press?

Hahaha, pry those mills from my cold dead fingers!

I won't be getting any new systems that don't cut titanium, nor will I likely buy any new materials until the RIGHT resins get here.

I'm just glad I pulled out of the milling center business a few years back and re-focused on dentist customers. Unless the center is one lean, mean operation, it's too cut throat for me.
 
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KAJayne

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Hey there--new to this forum. I am an RA professional (in medical devices for almost 16 years). I recently joined a manufacturer of sleep apnea devices. I have worked in regulated industry for years and I will confirm that good manufacturing practices make good business sense. Not only do they ensure safe and effective devices are produced, they reduce waste, non-conformances, and increase customer satisfaction--which equals higher profits.
 
Tom Moore

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Mark,

Are you going to get Medical Device ISO 13485-2003 certification? I believe in the end the easiest path is going to be paying for third party certification and annual inspections to satisfy FDA registration requirements. Texas uses the NBC/CDT as a standard for registering a lab to do business with a Texas Dentist. I can see the FDA doing something very similar.
 
Mark Jackson

Mark Jackson

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Mark,

Are you going to get Medical Device ISO 13485-2003 certification? I believe in the end the easiest path is going to be paying for third party certification and annual inspections to satisfy FDA registration requirements. Texas uses the NBC/CDT as a standard for registering a lab to do business with a Texas Dentist. I can see the FDA doing something very similar.

I may, but not at the moment. If we do it, it will be to satisfy some contracts we are working on with a manufacturer who asked if we would be willing to do it.
 
Mark Jackson

Mark Jackson

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Hey there--new to this forum. I am an RA professional (in medical devices for almost 16 years). I recently joined a manufacturer of sleep apnea devices. I have worked in regulated industry for years and I will confirm that good manufacturing practices make good business sense. Not only do they ensure safe and effective devices are produced, they reduce waste, non-conformances, and increase customer satisfaction--which equals higher profits.

That's right! Are you in Texas by any chance?
 
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KAJayne

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Yes, I am in Texas--and I love my great state:)
 
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