Identity
- Trade Name
- ClearVu Mini Ceramic Brackets FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Upper 5-5 Cuspid/Bicuspid with Hooks, 0.56 mm (.022") Bondable FDA UDI
- Model / Reference
- 297-409CV FDA UDI
- Description
- Upper 5-5 Cuspid/Bicuspid with Hooks, 0.56 mm (.022") Bondable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029005040 FDA UDI
- 510(k) Number
- K950992 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthodontic bracket, ceramic
ClearVu Mini Ceramic Brackets are a high-quality, single-patient orthodontic bracket designed for upper molars. These ceramic brackets feature a unique design with hooks and a metal insert slot for the archwire, ensuring a secure and durable bond. With their low friction surface, they promote smooth tooth movement and minimize the risk of wear.
Similar devices
Also classified as Orthodontic bracket, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
- Experience — GC Orthodontics America Inc. · Class II
- Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- EXPERIENCE® — GC Orthodontics America Inc. · Class II
- APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II
- NeoLucent Plus — Ortho Organizers, Inc. · Class II
- Experience — GC Orthodontics America Inc. · Class II
Cleared under the same submission
K950992 also covers:
- Ceramic/Metal Combination Kits — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Ceramic Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Readi-Base Bracket — TP ORTHODONTICS, INC.
- ClearVu Mini Readi-Base Bracket — TP ORTHODONTICS, INC.
- ClearVu Mini Readi-Base Brackets — TP ORTHODONTICS, INC.
- ClearVu Mini Readi-Base Brackets — TP ORTHODONTICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Tp Orthodontics, Inc.
Sources (1)
- FDA UDI e25f6941-800b-4b48-bd1d-927be5f8c65e 35 fields · synced Jul 20, 2026