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The FRIALIT-2® EstheticBase Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

The FRIALIT-2® EstheticBase Abutment is part of the FRIALIT-2® Dental Implant System. The EstheticBase Abutment is intended for the fabrication of screw-retained or cementable crowns and bridges. The EstheticBase Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each EstheticBase Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The EstheticBase Abutment is available with a straight or angled configuration.

I apologize, but this document, a 510(k) premarket notification letter from the FDA, does not contain information about the acceptance criteria or a study proving device performance as requested.

The document is a clearance letter stating that the FRIALIT-2 EstheticBase Abutment is substantially equivalent to a legally marketed predicate device (Nobel BioCare TiAdapt Abutment System). It confirms that the device can be marketed subject to general controls and, if applicable, special controls or PMA requirements.

The "Summary of Safety and Effectiveness" section (Page 3-5) provides device identification, describes the device, identifies the predicate device, states the intended use, and discusses the technological characteristics. It asserts that the new device is "substantially equivalent" to the predicate in design, functionality, materials, and intended use. However, it does not detail any specific performance criteria, quantitative measures, or a study design and results showing that the device meets those criteria.

Therefore, I cannot provide the requested information from this document.

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