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Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.

The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.

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I am sorry, but based on the provided text, there is no information regarding acceptance criteria related to device performance or a study demonstrating that the device meets such criteria.

The document is an FDA 510(k) clearance letter for two dental devices: "Ceramic Hextop Abutment" and "SynOcta® In-Ceram Coping" (also referred to as "ITI® Dental Implant System - Ceramic Coping"). This type of letter addresses substantial equivalence to existing legally marketed predicate devices, not performance criteria or clinical study results in the manner requested.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot provide the requested information.

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