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K Number
K993249
Device Name
OPC LOW WEAR OPAQUE PORCELAIN
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
1999-11-29

(62 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
Panel
DE
Reference & Predicate Devices
K982377,K910303
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

OPC Low Wear Opaque Porcelain is a porcelain powder, which will be bonded to metal copings to form dental restorations. Subsequent layers of translucent porcelains will be fired on top to complete the restoration. Particularly, to be used with OPC Low Wear Porcelain, K982377 to cover the metal restoration.

Device Description

OPC Low Wear Opaque Porcelain will be used for porcelain-fused to metal restorations on high expansion alloys by or on the order of a dentist. OPC Low Wear Opaque Porcelain contains opacifiers to cover the metal on porcelain-fused to metal restorations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment.

AI/ML Overview

I apologize, but the provided text from K993249 does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a premarket notification (510(k) summary and FDA decision letter) for a dental porcelain product (OPC Low Wear Opaque Porcelain). Its purpose is to demonstrate substantial equivalence to previously approved devices, not to present a detailed study on device performance against specific acceptance criteria.

The 510(k) summary states:

  • "We believe that OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, which have previously been approved by the FDA, are substantially equivalent."
  • "The safety and effectiveness is not affected because OPC Low Wear Opaque Porcelain only differs from the predicate devices by adding opacifiers to hide the metal of the restorations and Zinc Oxide help achieve adequate bond to the metal."

This indicates that the manufacturer's claim of safety and effectiveness rests on the substantial equivalence to predicate devices, rather than on independent studies demonstrating performance against novel acceptance criteria.

Therefore, I cannot provide the requested table or information as it is not present in the given text.

§ 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.