Identity
- Trade Name
- Empower Bracket EUDAMEDEmpower2 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Empower Bracket EUDAMED1 PAT SETUP SL EMPOWER DUAL ACT ROTH 018 U/L 5X5 W/HK 3,4,5 STICKY BX FDA UDI
- Model / Reference
- 126-029950 EUDAMEDFDA UDI
- Description
- 1 PAT SETUP SL EMPOWER DUAL ACT ROTH 018 U/L 5X5 W/HK 3,4,5 STICKY BX FDA UDI
Identifiers
- Catalog Number
- 126-029950 FDA UDI
- Primary DI / UDI-DI
- 00190746145704 EUDAMEDFDA UDI
- Basic UDI-DI
- 01907460000124DM EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic tube
Empower Bracket by American Orthodontics — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic tube.
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
- L4R BRACANIC CAPELOZZA I .022 PC C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01907460000124DM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Orthodontics
- EUDAMED SRN
- US-MF-000007702
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 26fd553e-6c3d-497c-bc8f-90920bfe91ba 61 fields · synced Jul 23, 2026
- FDA UDI 607f7107-9deb-4c59-8449-d4046f5597ac 35 fields · synced May 30, 2026