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Empower Bracket

by American Orthodontics 1,000+ variants

Ref 585-3522B

Empower Bracket (585-3522B) 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 25 Mar 2026 (UDI-DI 00190746122071), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

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
United StatesGUDID listing GUDID Number00190746122071 UDI-DI Date25 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number01907460000124DM Basic UDI-DI 00190746122071UDI-DIDate31 Jul 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01907460000124DM registered 31 Jul 2025 Active
  • FDA GUDID UDI-DI 00190746122071 listed 25 Mar 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 01907460000124DM
  2. Listed FDA GUDID 00190746122071

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  • Withdrawn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

Generic name
Orthodontic bracket, metal
Model / Ref / Catalog
585-3522B
Primary DI / UDI-DI
00190746122071
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
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)