Identity
- Trade Name
- Orthodontic Ceramic Bracket EUDAMEDVAR-22-553 FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Orthodontic Ceramic Bracket EUDAMED
- Model / Reference
- VAR-22-553 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046016186 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800046016186 EUDAMED
- 510(k) Number
- K201410 FDA UDI
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Var-22-553 by GNI Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Self-ligating orthodontic bracket.
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- ADITEK — ADITEK DO BRASIL S/A
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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-18-331 — GNI Co., Ltd
- RCM-18-503 — GNI Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GNI Co., Ltd
Sources (2)
- FDA UDI df865529-3ba7-4ef6-8992-7e5505197af1 33 fields · synced Jun 18, 2026
- EUDAMED 14f61c2b-1873-47d9-b3ac-bbe811ec6074 61 fields · synced Jun 18, 2026