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K Number
K974906
Device Name
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
1998-03-24

(83 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K992879
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding adhesive restoration techniques.
Direct filling technique:
· Adhesive bonding of composite materials to natural enamel and dentine (coltene® SYNERGY, coltène® Brilliant Dentin/Enamel/Incisal).
Indirect restorative techniques:
· Adhesive bonding of ceramic and composite patterns with coltene® Duo Cement to natural enamel and dentine.
Adhesive bonding of other dental materials:
· composite materials to pretreated ceramics
· composite material to composite material
· composite material to pretreated metals
· dentine sealing
Sclerotic dentin:
· Use 35 % phosphoric acid for 30 s (e.g. coltene® Etchant Gel S)

Device Description

Coltene® ONE COAT BOND is a light-cured, multipurpose, one-component adhesive agent for adhesive restoration techniques in dentistry. Coltène® ETCHANT 15 is a gel used for etching of dentine and enamel before the application of coltène® ONE COAT BOND.

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "One Coat Bond Dentin/Enamel Adhesive System." It does not contain a study description, acceptance criteria, or performance data for the device. Therefore, I cannot generate the requested information based on the provided text.

The letter explicitly states: "We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates that the device was cleared based on demonstrating substantial equivalence to a legally marketed predicate device, rather than through a a new clinical study with acceptance criteria and performance reporting as you've requested.

The document also includes an "Indications For Use" statement and a "Definition" and "Composition" for the product, but these do not constitute a study or performance data.

§ 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.