Empower Bracket
by American Orthodontics 1,000+ variants
Ref 585-2302AB, 585-1302B, 575-4517BCC, 485-330, 585-330CC, 585-340VSCC, 475-18-93417HD, 575-84412BCC, 485-22-94522CC, 485-74417CC, 485-2302ABCC, 585-74417BCC, 575-74417CC, 585-22-91412, 485-437B, 575-4412B, 475-18-94417HD, 475-237B, 575-84517BCC, 575-2407B, 575-18-93517, 475-4106CC, 126-038589, 475-81407B, 126-038566, 585-84417B, 575-18-93522HD, 485-22-94522, 475-73412B, 485-22-94517, 475-18-93517CC, 475-74417, 575-18-93412, 475-18-93517HDCC, 475-1302, 475-330, 485-230BCC, 585-73417BCC, 575-4412, 585-3417CC, 485-22-93407HD, 485-71412B, 585-84417CC, 585-22-92407, 485-22-94417HDCC, 126-038585, 485-22-93417HD, 575-72407, 575-81407BCC, 485-3522B, 585-1117
Active
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01907460000124DM | Date31 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 585-2302AB, 585-1302B, 575-4517BCC, 485-330, 585-330CC, 585-340VSCC, 475-18-93417HD, 575-84412BCC, 485-22-94522CC, 485-74417CC, 485-2302ABCC, 585-74417BCC, 575-74417CC, 585-22-91412, 485-437B, 575-4412B, 475-18-94417HD, 475-237B, 575-84517BCC, 575-2407B, 575-18-93517, 475-4106CC, 126-038589, 475-81407B, 126-038566, 585-84417B, 575-18-93522HD, 485-22-94522, 475-73412B, 485-22-94517, 475-18-93517CC, 475-74417, 575-18-93412, 475-18-93517HDCC, 475-1302, 475-330, 485-230BCC, 585-73417BCC, 575-4412, 585-3417CC, 485-22-93407HD, 485-71412B, 585-84417CC, 585-22-92407, 485-22-94417HDCC, 126-038585, 485-22-93417HD, 575-72407, 575-81407BCC, 485-3522B, 585-1117
- Primary DI / UDI-DI
- 00190746191268, 00190746191206, 00190746193699, 00190746190940, 00190746194023, 00190746191749, 00190746122781, 00190746194511, 00190746195990, 00190746196584, 00190746196010, 00190746195389, 00190746193804, 00190746175220, 00190746191527, 00190746114656, 00190746122774, 00190746190650, 00190746194559, 00190746203664, 00190746132629, 00190746193118, 00190746062780, 00190746071805, 00190746062544, 00190746122583, 00190746132667, 00190746132490, 00190746071645, 00190746132452, 00190746192616, 00190746071737, 00190746132544, 00190746192623, 00190746190551, 00190746190667, 00190746196041, 00190746195341, 00190746203749, 00190746195105, 00190746203619, 00190746072581, 00190746195570, 00190746175107, 00190746195969, 00190746062735, 00190746132445, 00190746121463, 00190746194399, 00190746072161, 00190746190186
- Basic UDI-DI
- 01907460000124DM
- EMDN code
- Q010403 Orthodontic brackets and buttons
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000007702
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from American Orthodontics
Properties
Other properties (14)
- 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