Identity
- Trade Name
- APC™ Flash-Free Clarity™ SL FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 3x3 3Hk .022 Kt FDA UDI
- Model / Reference
- 4007-133 FDA UDI
- Description
- Clarity(TM) SL Self-Ligating Bracket APC(TM) Flash-Free MBT(TM) U 3x3 3Hk .022 Kt FDA UDI
Identifiers
- Catalog Number
- 4007-133 FDA UDI
- Primary DI / UDI-DI
- 00652221165862 FDA UDI
- 510(k) Number
- K062305 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
- 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™ Flash-Free Clarity™ SL 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
K062305 also covers:
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 3M UNITEK CORPORATION
- APC™ Flash-Free Clarity™ SL — 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 |
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Manufacturer
- Manufacturer
- 3m Unitek Corporation
Sources (1)
- FDA UDI 488a0d4c-f13a-4670-9699-9efee2b1f2b6 36 fields · synced May 30, 2026