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K Number
K030644
Device Name
CONTEC DUO, CONTEC LC, CONTEC LCR
Manufacturer
DENTAURUM
Date Cleared
2003-11-21

(266 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

ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.

Device Description

ConTec Duo, ConTec LC, Contec LCR are adhesive compounds

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for dental adhesive devices (ConTec Duo, ConTec LC, ConTec LCR). It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, study data, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot answer the request with the information provided. The typical 510(k) clearance letter focuses on regulatory approval based on substantial equivalence, not detailed study results as would be found in a clinical trial report or a scientific publication.

§ 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.