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Ceramic Bracket Ice Clear
FDA UDIClass II (US FDA UDI)
by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda
Identity
- Trade Name
- CERAMIC BRACKET ICE CLEAR FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- CERAMIC BRACKET ICE CLEAR ROTH 0,022 4 SETS - 1 OFF (PROMOTIONAL) FDA UDI
- Model / Reference
- 10.87.2901 FDA UDI
- Description
- CERAMIC BRACKET ICE CLEAR ROTH 0,022 4 SETS - 1 OFF (PROMOTIONAL) FDA UDI
Identifiers
- Catalog Number
- 10.87.2901 FDA UDI
- Primary DI / UDI-DI
- 07908611204301 FDA UDI
- 510(k) Number
- K222847 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
Ceramic Bracket Ice Clear by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthodontic bracket, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
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- 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
K222847 also covers:
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
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
Sources (1)
- FDA UDI d50f7b8d-4e43-4d06-9c92-1ef9d838db50 35 fields · synced Jun 7, 2026