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Empower Bracket

by American Orthodontics 1,000+ variants

Ref 585-83417

Empower Bracket (585-83417) is a device classified as Class IIa in the EU and Class I in the US made by American Orthodontics, registered in EUDAMED on 31 Jul 2025 (Basic UDI-DI 01907460000124DM) and listed in FDA GUDID since 29 Dec 2016 (UDI-DI 00190746013768), withdrawn (EUDAMED), not in commercial distribution (GUDID) as of 23 Oct 2026.

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000124DM Basic UDI-DI 00190746013768UDI-DIDate31 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00190746013768 UDI-DI Date29 Dec 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01907460000124DM registered 31 Jul 2025 Withdrawn
  • FDA GUDID UDI-DI 00190746013768 listed 29 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190746013768
  2. Registered EUDAMED 01907460000124DM

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  • Withdrawn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  • European Union CE/MDR Withdrawn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
Empower2 GUDID
Generic name
Orthodontic bracket, metal
Model / Ref / Catalog
585-83417
Primary DI / UDI-DI
00190746013768
Basic UDI-DI
01907460000124DM
FDA product code
EJF
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic bracket, metal
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
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Related devices

Category: Orthodontic tube

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)