LogoFDA 510(k) Search
K Number
K990817
Device Name
IPS D.SIGN PORCELAIN
Manufacturer
IVOCLAR NORTH AMERICA, INC.
Date Cleared
1999-04-06

(26 days)

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

Intended Use: d.Sign Porcelain is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental device called "IPS D.Sign Porcelain". This document primarily focuses on the regulatory approval of the device and does not contain information about acceptance criteria, clinical studies, or performance metrics in the way you've described.

Therefore, I cannot extract the requested information regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for the test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. Method for establishing ground truth for the training set.

This document confirms substantial equivalence to a predicate device and allows the manufacturer to market the product. It doesn't detail the specific testing and studies that would normally be associated with proving these performance criteria.

§ 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.