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K Number
K033760
Device Name
ONE COAT SE BOND
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
2004-01-23

(52 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

One Coat SE Bond, a self etching dental adhesive, is indicated for the following:

  • The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
  • The bonding of direct fillings of composite or compomer. .
  • The bonding of composite to amalgam. .
  • The repairing of metal/ceramic, ceramic or composite restorations. .
  • The sealing of sensitive teeth. .
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a dental adhesive, not a study report or a document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The document primarily focuses on regulatory approval rather than technical study details.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.