Identity
- Trade Name
- OnBrace Crown UR7 (5/pk) FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Model / Reference
- 901323 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8199013230 FDA UDI
- FDA Product Code
- ECM FDA UDI
- GMDN Term
- Orthodontic metal band 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
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
No
FDA UDI
Category: Orthodontic metal band
OnBrace Crown UR7 (5/pk) by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic metal band.
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- The Orthodontic Store — Young Innovations, Inc. · Class I
- CONLIN MOLAR BANDS — ORTHO ARCH COMPANY INC · Class I
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
- Specialty Appliances, Llc
Sources (1)
- FDA UDI b9c54440-28d6-4da2-ab11-71b6ec2f9278 32 fields · synced Jun 6, 2026