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K Number
K032165
Device Name
VINTAGE AL
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2003-09-16

(63 days)

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

Vintage AL is dental porcelain used for fabricating crown restorations (all ceramic crown), built up on a ceramic substructure (aluminum oxide-based) and then fired.

Device Description

Not Found

AI/ML Overview

The provided FDA 510(k) clearance letter (K032165) does not contain information regarding detailed acceptance criteria, device performance studies, or the methodologies typically associated with assessing the performance of software-based medical devices or diagnostic imaging aids.

This document is a clearance for "Vintage AL," which is described as a "Porcelain Powder for Clinical Use" and "dental porcelain used for fabricating crown restorations." The clearance is based on substantial equivalence to predicate devices, a process that relies on demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Therefore, most of the requested information, which pertains to performance studies and reader studies, would not be found in this type of 510(k) clearance for a material like dental porcelain. The clearance focuses on general controls and substantial equivalence, not detailed performance metrics from clinical trials or AI/software validation studies.

Based on the provided text, I cannot answer the following questions:

  1. A table of acceptance criteria and the reported device performance: Not applicable for this type of device and clearance document.
  2. Sample sized used for the test set and the data provenance: Not applicable.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/diagnostic device).
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.