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K Number
K191794
Device Name
Vintage Art Universal
Manufacturer
Shofu Dental Corporation
Date Cleared
2019-10-03

(92 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Shade adjustment of ceramic restorations

Device Description

Not Found

AI/ML Overview

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.

§ 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.