Identity
- Trade Name
- Empower Clear FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-17 A=0 R=0 FDA UDI
- Model / Reference
- 1485-22-4417 FDA UDI
- Description
- COSMETIC SL EMPOWER CLEAR INTERACT LR 1ST BICUSPID 022 T-17 A=0 R=0 FDA UDI
Identifiers
- Catalog Number
- 1485-22-4417 FDA UDI
- Primary DI / UDI-DI
- 00190746001079 FDA UDI
- 510(k) Number
- K122753 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Empower Clear by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122753 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- American Orthodontics
Sources (1)
- FDA UDI 23ccf257-82d9-41bc-b067-9c9795cad629 37 fields · synced Jun 9, 2026