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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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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