Identity
- Trade Name
- dentaform® FDA UDI
- Generic Name
- Orthodontic metal band FDA UDI
- Device Name
- Mini-Assortment dentaform® Snap Bands, Tooth 16, Roth 22/ For further information please visit our online-shop on our website www.dentaurum.de FDA UDI
- Model / Reference
- 878-064-22 FDA UDI
- Description
- Mini-Assortment dentaform® Snap Bands, Tooth 16, Roth 22/ For further information please visit our online-shop on our website www.dentaurum.de FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011878064220 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
- 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
No
FDA UDI
dentaform® by Dentaurum — 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
- Dentaurum
Sources (1)
- FDA UDI 142e50a7-3a20-4724-adff-c829b565b8d3 36 fields · synced Jun 1, 2026