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Empower Tube

by American Orthodontics 292 variants

Ref 008-18-1614H

Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 22 Oct 2026. What this means

Overview

Empower Tube is a Class IIa medical device designed to provide precise and effective treatment for patients with orthodontic needs. Utilizing advanced technology, this device enables clinicians to achieve optimal results while minimizing the risk of complications.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000126DR Basic UDI-DI 00190746132308UDI-DIDate31 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00190746132308 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  • Withdrawn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  • European Union CE/MDR Withdrawn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 Tube EUDAMED
Empower 2® GUDID
Generic Name
Orthodontic tube
Model / Ref / Catalog
008-18-1614H
Primary DI / UDI-DI
00190746132308
Basic UDI-DI
01907460000126DR
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 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

Manufacturer details

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

Related devices

Category: Orthodontic tube

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 (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No