Identity
- Trade Name
- ACCENT FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Accent Ceramic Orthodontic Bracket Edgewise 022 Lo1/2 FDA UDI
- Model / Reference
- A0154 FDA UDI
- Description
- Accent Ceramic Orthodontic Bracket Edgewise 022 Lo1/2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817713020259 FDA UDI
- 510(k) Number
- K052245 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
Category: Orthodontic bracket, ceramic
Accent by Orthoquest, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic bracket, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
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- 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
K052245 also covers:
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
- ACCENT — ORTHOQUEST, INC.
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
- Orthoquest, Inc.
Sources (1)
- FDA UDI b3175d89-8daf-45ff-9533-4fb2599e216b 34 fields · synced Jun 8, 2026