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K Number
K012180
Device Name
A-WEAR
Manufacturer
BISCO, INC.
Date Cleared
2001-09-05

(55 days)

Product Code
EBF,JUL
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K012180
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Direct or indirect class III, IV, and V restorations.
  2. Diastema closures.
  3. Composite restorations bonded to tooth structure.
  4. Composite restorations bonded to metal.
  5. Composite restorations bonded to composite or fiber-reinforced substructure.
  6. Composite restorations bonded to porcelain.
  7. Direct or indirect veneers.
Device Description

A-Wear™ provides the dentist with a composite designed to yield high resistance to wear and abrasion and excellent polishing characteristics. In addition to these properties, Aand ublighty translucent (opacity

AI/ML Overview

The provided text is a 510(k) submission for a dental composite material called A-Wear™. While it provides information about the device's intended use and legal marketing status, it does not contain details about specific acceptance criteria and the studies that prove the device meets these criteria in the way you've outlined.

The document discusses the device's properties (high resistance to wear and abrasion, excellent polishing characteristics, translucent opacity) by description and comparison to a predicate device (Micronew™), but it does not present quantifiable acceptance criteria or study results to demonstrate these claims.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The information requested typically comes from performance testing sections of a submission, which are not present here.

However, I can extract the following limited information where available:

Acceptance Criteria and Device Performance (Based on descriptive claims, no quantitative data available):

Acceptance CriteriaReported Device Performance
High resistance to wear and abrasionA-Wear™ is designed to yield high resistance to wear and abrasion.
Excellent polishing characteristicsA-Wear™ has excellent polishing characteristics.
OpacityA-Wear™ is *highly translucent (opacity

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.