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K Number
K142880
Device Name
DMRC Light Cure Orthodontic Adhesive System
Manufacturer
Daville Materials LLC
Date Cleared
2015-02-04

(125 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DMRC Light Cure Orthodontic Adhesive System is a Light Cure Adhesive for bonding metal and ceramic brackets to tooth surfaces

Device Description

Not Found

AI/ML Overview

There is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is an FDA 510(k) clearance letter for a dental adhesive, which primarily discusses regulatory classification, general controls, and good manufacturing practices. It also includes the indications for use for the device. Clinical study details, performance metrics, and acceptance criteria are not part of this specific regulatory communication.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.