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Empower Bracket

by American Orthodontics 1,000+ variants

Ref 485-22-93407HD

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

Empower Bracket is a medical device designed for the placement of orthodontic implants. It is used to support and stabilize dental implants, improving their functionality and longevity. With its advanced features and capabilities, Empower Bracket has become a leading solution in the field of orthodontics.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000124DM Basic UDI-DI 00190746132360UDI-DIDate31 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00190746132360 UDI-DI Date5 Jul 2018ListedStatusListed GUDID: not 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Empower Bracket EUDAMED
Empower 2® GUDID
Generic name
Orthodontic tube
Model / Ref / Catalog
485-22-93407HD EUDAMED
008-18-3610H GUDID
Primary DI / UDI-DI
00190746132360
Basic UDI-DI
01907460000124DM
FDA product code
DZD
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic tube
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
485-22-93407HD
GUDID
008-18-3610H
Device classEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000007702
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number

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
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No