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K Number
K963735
Device Name
COJET SYSTEM
Manufacturer
ESPE GMBH & CO. KG.
Date Cleared
1996-11-27

(71 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K925027,K960547,K900510,K913966,K911061,K913857,K913965,K833757
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CoJet™-System's intraoral adhesive restoration repair and adhesive cementation uses include:

  • adhesive repair of defects in porcelain
  • adhesive repair of defects in porcelain with exposed metal -
  • adhesive repair of defects in composite -
  • adhesive repair of defects in composite with exposed metal
  • conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
  • conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
Device Description

4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The components are CoJet™-Sand, a silane coupling agent, a bonding material, and an Opaquer.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML or diagnostic performance. The document is a 510(k) summary for a dental adhesive system (CoJet™-System) and focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information, as there is no data related to:

  1. Acceptance criteria and reported device performance in a diagnostic sense (e.g., sensitivity, specificity, AUC).
  2. Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance in the context of an AI/ML device or diagnostic test.

The document discusses the regulatory clearance of a dental product based on its components and their prior clearances, with a brief mention of "performance data demonstrate that the products' performance is not affected by intraoral preparation and use." However, it does not elaborate on what this performance data entails, nor does it present specific metrics or study designs relevant to the questions asked.

§ 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.