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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="ChrisBWJ" data-source="post: 195252" data-attributes="member: 3124"><p>There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced. The FDA still considers them an abutment and they fall under the 510k requirement. This is the information that I am hearing from the FDA and through performance standards development committees I am a part of. How it all plays out remains to be seen.</p><p></p><p>Oh and the current registration fee for the FDA is $3,845 for 2016, and estimated to be $3,872 for 2017. Thank you Obamacare!</p><p></p><p>This fee covers only registration, it does not include the cost of submitting a 510k, fatigue testing, development and implementation of an acceptable QMS, etc..</p></blockquote><p></p>
[QUOTE="ChrisBWJ, post: 195252, member: 3124"] There isn't a traditional "abutment post" as we would expect in an implant abutment, but the same mechanical factors and forces are in play. If the implant to occlusal force angle exceeds what the system was tested to, then it could cause failure of the implant, the Ti-insert, or Zirconia topper. Design parameters must still be enforced. The FDA still considers them an abutment and they fall under the 510k requirement. This is the information that I am hearing from the FDA and through performance standards development committees I am a part of. How it all plays out remains to be seen. Oh and the current registration fee for the FDA is $3,845 for 2016, and estimated to be $3,872 for 2017. Thank you Obamacare! This fee covers only registration, it does not include the cost of submitting a 510k, fatigue testing, development and implementation of an acceptable QMS, etc.. [/QUOTE]
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Lab talk, the good, the bad, and the ugly
Dental-CAD
FDA & milling abutments in house
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