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Outsourcing Concerns- FDA Regulations-ADA Regulati
DAMAS, GMP Study Club in FaceBook
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<blockquote data-quote="Alistar" data-source="post: 62699" data-attributes="member: 2295"><p>Mark,</p><p></p><p>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?</p><p></p><p>Does the FDA really have the man power and resources to inspect all the labs and dental offices filling implant Rx's?</p><p></p><p>Wouldn't this only affect "milling" labs, or would this affect those that do a digital design and then outsource the milling?</p><p></p><p>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. </p><p></p><p>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.</p><p></p><p>I only say this because of what I've seen the last 2-3 years with the increase in implant placement. </p><p></p><p>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! </p><p></p><p>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!</p><p></p><p>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.</p><p></p><p>I'm not venting this directly at you Mark. I'm just thinking out loud, and trying to make sense of this.</p></blockquote><p></p>
[QUOTE="Alistar, post: 62699, member: 2295"] 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. [/QUOTE]
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