Identity
- Trade Name
- OMNIARCH® FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- OmniArch® M-P 018/UR2 14T 9A FDA UDI
- Model / Reference
- 77-121-70 FDA UDI
- Description
- OmniArch® M-P 018/UR2 14T 9A FDA UDI
Identifiers
- Catalog Number
- 77-121-70 FDA UDI
- Primary DI / UDI-DI
- D80777121701 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
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Omniarch® by Dentsply Sirona Orthodontics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI c5b5f4f1-4fd1-4b9f-8a1c-7c640b1dcd96 36 fields · synced Jun 9, 2026