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Thino Roth Bracket, .022, Mini Size, w/hs at #3
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Thino Roth Bracket,.022,Mini Size,w/hs at #3 FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Model / Reference
- 1212-55-3H FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973329320088 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
No
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
Yes
FDA UDI
Category: Orthodontic bracket, metal
Thino Roth Bracket, .022, Mini Size, w/hs at #3 by Astar Orthodontics Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Orthodontic bracket, metal.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
Sources (2)
- FDA UDI c3c99234-df96-4280-a47d-ca86fe297b02 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026