(105 days)
Zirprime is indicated in the anterior and posterior segments for:
crowns
telescopic primary crowns
multi-unit bridges (with no more than two pontics between abutment crowns)
Zirprime can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental device named "Zirprime," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The document discusses:
- The FDA's review and determination of substantial equivalence for Zirprime.
- Regulatory requirements for marketing the device.
- Contact information for various FDA offices.
- Indications for Use for Zirprime (crowns, telescopic primary crowns, multi-unit bridges).
However, it does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or expert qualifications for a test set.
- Ground truth establishment methods.
- MRMC studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.