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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.

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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.

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Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.

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I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is primarily a letter from the FDA to Noritake Company, Incorporated, confirming the substantial equivalence of their device, Zirprime, a porcelain powder for clinical use (Product Code: EIH, Regulation Number: 21 CFR 872.6660). It outlines regulatory compliance requirements but does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Information about training sets.

To obtain this kind of information, you would typically need to consult a more detailed submission document, such as the full 510(k) submission, if it were publicly available and contained performance data. The provided document is a notification of clearance, not a technical report on performance.

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