Identity
- Trade Name
- CHIC/Rhodium FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- CHIC U4-4/RHU5L5-5 MBT022 HK345 FDA UDI
- Model / Reference
- 14/38-2CC5-R020 FDA UDI
- Description
- CHIC U4-4/RHU5L5-5 MBT022 HK345 FDA UDI
Identifiers
- Catalog Number
- 14/38-2CC5-R020 FDA UDI
- Primary DI / UDI-DI
- D78814382CC5R0201 FDA UDI
- FDA Product Code
- NJM FDA UDIEJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI872.5410 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
Yes
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, metalOrthodontic bracket, ceramic
CHIC/Rhodium by GC Orthodontics America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- GC Orthodontics America Inc.
Sources (1)
- FDA UDI dbbe5e7a-b22c-4cae-9b9a-e934540cf29f 35 fields · synced Jun 8, 2026