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Ceramic brackets self-ligating

by Bernhard Förster GmbH 800 variants

Ref C715-0413-010

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Overview

Our Ceramic brackets self-ligating device is a Class IIa medical device designed for precise and safe implantation, offering high reliability and minimal complications. Developed with advanced ceramic materials, this device provides superior stability and durability in various surgical procedures.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EFOR070105F9 Basic UDI-DI EFORC71504130101UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberEFORC71504130101 UDI-DI Date30 Sep 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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 GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TruKlear®
Generic name
Orthodontic bracket, ceramic
Model / reference
C715-0413-010
Primary DI / UDI-DI
EFORC71504130101
Basic UDI-DI
++EFOR070105F9
Unit of use DI
EFORC7150413010001
510(k) Number
FDA product code
NJM
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic bracket, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.5470
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006256

Related devices

Category: Orthodontic tube

Other devices from Bernhard Förster GmbH

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (21)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No