U.S. FDA Medical Device Endosseous Dental Implant Abutment Requirements: Endosseous Dental Implant Abutment
FDA Medical Device Definition: An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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