Identity
- Trade Name
- 3M™ Unitek™ FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A 6DistalRotation Hk .018 5/Pk FDA UDI
- Model / Reference
- 017-379 FDA UDI
- Description
- Unitek(TM) Miniature Twin Bracket Roth LL3 -11T/5A 6DistalRotation Hk .018 5/Pk FDA UDI
Identifiers
- Catalog Number
- 017-379 FDA UDI
- Primary DI / UDI-DI
- 00652221006356 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
3M™ Unitek™ by 3m do Brasil Ltda. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3m do Brasil Ltda.
Sources (1)
- FDA UDI aa89c64f-94ef-4295-9f63-0f974dbfcd3b 36 fields · synced May 31, 2026