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K Number
K030977
Device Name
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
Manufacturer
DENTAURUM
Date Cleared
2003-08-25

(150 days)

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

Dentaurum MIX Two-paste Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

Device Description

Dentaurum MIX Two-paste Bracket Adhesive

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results.

§ 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.