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Lab talk, the good, the bad, and the ugly
Dental-CAD
FDA & milling abutments in house
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<blockquote data-quote="RJS8669" data-source="post: 195851" data-attributes="member: 5742"><p>Had an interesting discussion with someone with inside FDA information. The issue seems to derive from a worry about labs using CAD/CAM systems to create abutments or screw-retained restorations that exceed angle correction specifications for FDA-approved implants. In other words, they don't want a non-FDA compliant abutment or restoration causing the failure of an FDA-compliant implant. The suggestion was, in order, to be on the safe side of things, a lab would need to register with the FDA (cost appx. $3800, and rising every year); and institute a Quality Management System to track lot numbers, designs, failures, etc... It was suggested that the total cost to be FDA compliant would be somewhere in the $7500-$10,000 range for the average lab - potentially more.</p><p></p><p>Other insights include that using CAD/CAM (with the exception of Sirona) to design/mill ANY abutment head or full contour restoration for a Ti base is a violation of the ruling, although it appears to be perfectly okay to hand wax and either press or cast whatever you like - go figure. The other really odd thing was that dentists are allowed to ask for a lab to mill an abutment or a screw-retained restoration, but a lab cannot market the ability to do so unless they are FDA registered and in compliance. So, this is aimed squarely at labs - there is no consequence to doctor for using a non-FDA compliant product as long as they knowingly request it. I believe this was referred to as "going off-brand".</p><p></p><p>Lastly, abutments have been labeled as a medical device and will be subject to the medical device tax. It appears that the entity milling the abutment or the entity selling the pre-milled Ti blank will be liable for collecting the tax. So, labs that outsource to FDA compliant milling centers should be charged the tax but are not liable for collecting a tax from the dentist or patient. If you are FDA compliant and milling your own abutments then the Ti blank supplier would collect the tax. </p><p></p><p>I have also been alerted that Nobel and Straumann will be issuing statements on this ruling in the very near future..</p></blockquote><p></p>
[QUOTE="RJS8669, post: 195851, member: 5742"] Had an interesting discussion with someone with inside FDA information. The issue seems to derive from a worry about labs using CAD/CAM systems to create abutments or screw-retained restorations that exceed angle correction specifications for FDA-approved implants. In other words, they don't want a non-FDA compliant abutment or restoration causing the failure of an FDA-compliant implant. The suggestion was, in order, to be on the safe side of things, a lab would need to register with the FDA (cost appx. $3800, and rising every year); and institute a Quality Management System to track lot numbers, designs, failures, etc... It was suggested that the total cost to be FDA compliant would be somewhere in the $7500-$10,000 range for the average lab - potentially more. Other insights include that using CAD/CAM (with the exception of Sirona) to design/mill ANY abutment head or full contour restoration for a Ti base is a violation of the ruling, although it appears to be perfectly okay to hand wax and either press or cast whatever you like - go figure. The other really odd thing was that dentists are allowed to ask for a lab to mill an abutment or a screw-retained restoration, but a lab cannot market the ability to do so unless they are FDA registered and in compliance. So, this is aimed squarely at labs - there is no consequence to doctor for using a non-FDA compliant product as long as they knowingly request it. I believe this was referred to as "going off-brand". Lastly, abutments have been labeled as a medical device and will be subject to the medical device tax. It appears that the entity milling the abutment or the entity selling the pre-milled Ti blank will be liable for collecting the tax. So, labs that outsource to FDA compliant milling centers should be charged the tax but are not liable for collecting a tax from the dentist or patient. If you are FDA compliant and milling your own abutments then the Ti blank supplier would collect the tax. I have also been alerted that Nobel and Straumann will be issuing statements on this ruling in the very near future.. [/QUOTE]
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Lab talk, the good, the bad, and the ugly
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FDA & milling abutments in house
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