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BracePaste MTP Light Cure Primer

by American Orthodontics

510(k) K181910

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181910↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK181910 Date15 Oct 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BracePaste MTP Light Cure Primer is a dental agent classified as a resin for tooth bonding. It serves as a bonding primer designed to enhance adhesion between orthodontic brackets and tooth surfaces, ensuring durable bonding for fixed appliances.

This primer is supplied as a single-use dental material, intended for use in orthodontic procedures within clinical settings. It is regulated under FDA 510K clearance and MDR compliance, with a device classification of Class II. The product is non-sterile and must be handled in accordance with standard dental practice protocols.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the BracePaste MTP Light Cure Primer in orthodontic treatment?

    The BracePaste MTP Light Cure Primer is designed as a resin bonding primer to enhance adhesion between orthodontic brackets and tooth surfaces. This ensures a more durable bond for fixed appliances, helping to maintain stability during treatment.

  • Is the BracePaste MTP Light Cure Primer intended for single-use or repeated applications?

    The BracePaste MTP Light Cure Primer is explicitly supplied as a single-use dental material. This means each application requires a new unit, adhering to standard dental practice protocols for hygiene and safety.

  • How should the BracePaste MTP Light Cure Primer be stored, and is it sterile?

    The BracePaste MTP Light Cure Primer is non-sterile, so it must be handled in accordance with standard dental practice protocols. Storage should follow manufacturer guidelines to maintain its integrity, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data.

  • What regulatory pathways has the BracePaste MTP Light Cure Primer followed for approval?

    The device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II device under FDA regulations, indicating it has undergone a traditional clearance process through the Dental Advisory Committee (DE).

  • Are there different sizes or models of the BracePaste MTP Light Cure Primer, or is it a single formulation?

    The provided data does not specify multiple sizes or models of the BracePaste MTP Light Cure Primer. It is described as a single-use resin primer for orthodontic bonding, implying a standardized formulation without variations in packaging or application.