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Dentallabnetwork.com
Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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<blockquote data-quote="Tim Torbenson" data-source="post: 310357" data-attributes="member: 19412"><p>That is inaccurate. The FDA requirements are on the CAD and the milled components, not on the CAM or the mill. There is so much misinformation out there to scare you into buying overpriced systems like the Straumann or Sirona. The open systems are more affordable and easier to maintain. Most will also offer greater variety and options with your source for Ti bases or Ti blanks.</p><p></p><p>You can get any mix of CAD, CAM and equipment to mill the many options of 510(k) cleared Ti components. You will need to implement a Quality System and document some procedures to validate the process to satisfy the FDA. This is what we do, help labs to enter into these manufacturing processes and be compliant with the FDA. Our clients that were FDA audited, have experienced no problems with the FDA.</p><p></p><p>The FDA requirements are straightforward and not difficult to manage in any sized lab. There is just too many companies doing a good job of scaring lab owners. Shoot me a message and I will be happy to share the reality of the FDA requirements.</p></blockquote><p></p>
[QUOTE="Tim Torbenson, post: 310357, member: 19412"] That is inaccurate. The FDA requirements are on the CAD and the milled components, not on the CAM or the mill. There is so much misinformation out there to scare you into buying overpriced systems like the Straumann or Sirona. The open systems are more affordable and easier to maintain. Most will also offer greater variety and options with your source for Ti bases or Ti blanks. You can get any mix of CAD, CAM and equipment to mill the many options of 510(k) cleared Ti components. You will need to implement a Quality System and document some procedures to validate the process to satisfy the FDA. This is what we do, help labs to enter into these manufacturing processes and be compliant with the FDA. Our clients that were FDA audited, have experienced no problems with the FDA. The FDA requirements are straightforward and not difficult to manage in any sized lab. There is just too many companies doing a good job of scaring lab owners. Shoot me a message and I will be happy to share the reality of the FDA requirements. [/QUOTE]
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Outsourcing Concerns- FDA Regulations-ADA Regulati
List of FDA approved custom milled ti abutment blank/mill combo
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