Identity
- Trade Name
- QuicKlear FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only. FDA UDI
- Model / Reference
- C706-1046 FDA UDI
- Description
- The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only. FDA UDI
Identifiers
- Catalog Number
- C706-1046 FDA UDI
- Primary DI / UDI-DI
- EFORC7061046 FDA UDI
- 510(k) Number
- K090933 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — .018 Inch FDA UDI
Category: Orthodontic bracket, ceramic
QuicKlear by Forestadent Bernhard Förster GmbH — 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
- 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
Cleared under the same submission
K090933 also covers:
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
- QuicKlear — Forestadent Bernhard Förster GmbH
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
- Forestadent Bernhard Förster GmbH
Sources (1)
- FDA UDI 34b556de-23fd-44e8-b911-cabaaa586688 36 fields · synced May 30, 2026