Identity
- Trade Name
- RCM-18-331 FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Model / Reference
- RCM-18-331 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046017114 FDA UDI
- 510(k) Number
- K201410 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Self-ligating orthodontic bracket
Rcm-18-331 by GNI Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Self-ligating orthodontic bracket.
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Cleared under the same submission
K201410 also covers:
- RCE-18-051 — GNI Co., Ltd
- RCE-18-331 — GNI Co., Ltd
- RCE-18-551 — GNI Co., Ltd
- RCE-18-553 — GNI Co., Ltd
- RCE-22-301 — GNI Co., Ltd
- RCE-22-331 — GNI Co., Ltd
- RCE-22-501 — GNI Co., Ltd
- RCE-22-551 — GNI Co., Ltd
- RCM-18-031 — GNI Co., Ltd
- RCM-18-053 — GNI Co., Ltd
- RCM-18-503 — GNI Co., Ltd
- RCM-18-551 — GNI Co., Ltd
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
- GNI Co., Ltd
Sources (1)
- FDA UDI 17907ba6-398c-46f9-a08c-a59fdb49152a 33 fields · synced Jun 6, 2026