Identity
- Trade Name
- Fastbraces FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Model / Reference
- Clear Ceramic Brackets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006117306 FDA UDI
- 510(k) Number
- K130446 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Fastbraces by Orthoworld, L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K130446 also covers:
- FASTBRACES® Classic Clear LL/LR 1/2 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear LL3 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear LR3 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear U/L 4/5 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UL1 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UL2 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UL3 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UR1 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UR2 — Orthoworld, L.L.C.
- FASTBRACES® Classic Clear UR3 — Orthoworld, L.L.C.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthoworld, L.L.C.
Sources (1)
- FDA UDI c2c3ea74-b73e-4e6c-92df-acf41a5702cb 34 fields · synced May 30, 2026