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Shade adjustment of ceramic restorations

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I am sorry, but the provided text from the FDA letter (K191794) for "Vintage Art Universal" does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter for a dental porcelain powder, classifying it as a Class II device. It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls (registration, listing, GMP, labeling, adverse event reporting).
• The intended use of the device: "Shade adjustment of ceramic restorations."

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device).
• Details of a clinical study or performance study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding AI/human reader performance or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself unless specifically highlighted for a novel device or testing paradigm.

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Shade adjustment of Lithium disilicate and ceramic restorations

Not Found

The provided document is an FDA clearance letter for a dental device (porcelain powder) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It discusses the device's substantial equivalence to other legally marketed devices but does not detail performance metrics, study designs, or effectiveness. Therefore, I cannot extract the requested information from this document.

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Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.

Vintage Art is dental ceramic stain.

I am sorry, but the context provided does not contain the information requested. The document is an FDA 510(k) clearance letter for a dental ceramic product called "Vintage Art." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• Device Name: Vintage Art
• Regulation Number/Name: 872.6660 / Porcelain Powder for Clinical Use
• Regulatory Class: II
• Product Code: EIH
• Indications for Use: Dental ceramic stain for adjusting the shade of dental ceramic restorations or prostheses.

However, the provided text does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Ask a specific question about this device