brayks
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This is the laest way companies are obtaining 510(k) clearance for their implants and implant components-and its becoming a huge deal that I believe will only get bigger.
Under new FDA guidelines these companies obtain 510(k) clerance for their products as long as they only sell them in "closed manufacturing systems" where a "recepie" for porduction (which includes scanner, machine, materials, tooling, etc.) is followed. This is considered a PNP or Plug-n-Play scenaio.
The alternative is for the lab they are selling to, though (either directly or through distributor) has been certified by them (the implant company) as to producing quality, accurate abutments AND has in place a QMS (Quality Managemenet System) thereby assuring they are following GMP (Good Manufacturing Practices).
The FDA grants the implant company 510(k) cleaerance for their products under these conditions.
We are currently working with implant companies and labs to work under these conditions allowing sales for the implant companies and labs to be FDA compliant with minimum investment and worry-free (in terms of FDA compliance) fabrication of custom abuments.
We also work with evo820 who helps our clients set-up a QMS that enables compliance as it sets them up to be what the FDA considers a Certified Milling Center for an implant company whereby the can register as such with the FDA, buy the implant components, mill the abutments and sell them to their customers-all (implant company and lab) being FDA compliant.
Under new FDA guidelines these companies obtain 510(k) clerance for their products as long as they only sell them in "closed manufacturing systems" where a "recepie" for porduction (which includes scanner, machine, materials, tooling, etc.) is followed. This is considered a PNP or Plug-n-Play scenaio.
The alternative is for the lab they are selling to, though (either directly or through distributor) has been certified by them (the implant company) as to producing quality, accurate abutments AND has in place a QMS (Quality Managemenet System) thereby assuring they are following GMP (Good Manufacturing Practices).
The FDA grants the implant company 510(k) cleaerance for their products under these conditions.
We are currently working with implant companies and labs to work under these conditions allowing sales for the implant companies and labs to be FDA compliant with minimum investment and worry-free (in terms of FDA compliance) fabrication of custom abuments.
We also work with evo820 who helps our clients set-up a QMS that enables compliance as it sets them up to be what the FDA considers a Certified Milling Center for an implant company whereby the can register as such with the FDA, buy the implant components, mill the abutments and sell them to their customers-all (implant company and lab) being FDA compliant.
