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K Number
K020394
Device Name
APC PLUS ADHESIVE
Manufacturer
3M UNITEK
Date Cleared
2002-04-12

(65 days)

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

3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a dental adhesive (3M™ Unitek™ APC™ Plus Adhesive). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. However, it does not include any details about acceptance criteria for performance, studies demonstrating performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details are typically found in the 510(k) submission itself or in associated studies, not in the clearance letter.

§ 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.