Identity
- Trade Name
- RSE-22-031 FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Model / Reference
- RSE-22-031 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046017367 FDA UDI
- 510(k) Number
- K182672 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
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: Orthodontic bracket, ceramic
Rse-22-031 by GNI Co., Ltd — 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
K182672 also covers:
- RSE-18-031 — GNI Co., Ltd
- RSE-18-051 — GNI Co., Ltd
- RSE-18-053 — GNI Co., Ltd
- RSE-18-301 — GNI Co., Ltd
- RSE-18-331 — GNI Co., Ltd
- RSE-18-501 — GNI Co., Ltd
- RSE-18-503 — GNI Co., Ltd
- RSE-18-551 — GNI Co., Ltd
- RSE-18-553 — GNI Co., Ltd
- RSE-22-051 — GNI Co., Ltd
- RSE-22-053 — GNI Co., Ltd
- RSE-22-301 — 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 |
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Manufacturer
- Manufacturer
- GNI Co., Ltd
Sources (1)
- FDA UDI 51d84932-b9dd-4f97-b328-e7808b1ebf42 33 fields · synced Jun 1, 2026