Identity
- Trade Name
- APC™ II Unitek™ Gemini Clear FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .018 Kt FDA UDI
- Model / Reference
- 3117-101 FDA UDI
- Description
- Unitek(TM) Gemini Clear Ceramic Bracket APC(TM) II MBT(TM) U/L 5x5 3,4,5Hk .018 Kt FDA UDI
Identifiers
- Catalog Number
- 3117-101 FDA UDI
- Primary DI / UDI-DI
- 00652221169419 FDA UDI
- 510(k) Number
- K944286 FDA UDI
- FDA Product Code
- DYW FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic bracket, ceramic
APC™ II Unitek™ Gemini Clear by 3m Unitek Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
- Ceramic/Metal Combination Kits — TP ORTHODONTICS, INC. · Class II
- TipEdge PLUS Ceramic Readi-Base Bracket — TP ORTHODONTICS, INC. · Class II
- Experience — GC Orthodontics America Inc. · Class II
- EXPERIENCE® — GC Orthodontics America Inc. · Class II
- NeoLucent Plus — Ortho Organizers, Inc. · Class II
- ClearVu Mini Readi-Base Bracket — TP ORTHODONTICS, INC. · Class II
- Experience — GC Orthodontics America Inc. · Class II
Cleared under the same submission
K944286 also covers:
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
- APC™ II Unitek™ Gemini Clear — 3M UNITEK CORPORATION
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
- 3m Unitek Corporation
Sources (1)
- FDA UDI e5ad51f7-e42c-4bb0-8511-19d0306dbe0e 36 fields · synced Jun 8, 2026