Identity
- Trade Name
- OVC Hybrid FDA UDI
- Generic Name
- Preformed dental crown, permanent FDA UDI
- Device Name
- Package contains an OVC Hybrid in shade A3 for tooth number FDI 16.17 XL : USA 2-3 XL (Extra-Large), 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica. FDA UDI
- Model / Reference
- OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A3 FDA UDI
- Description
- Package contains an OVC Hybrid in shade A3 for tooth number FDI 16.17 XL : USA 2-3 XL (Extra-Large), 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and 1 x OVC Replica. FDA UDI
Identifiers
- Catalog Number
- 9421031793791 FDA UDI
- Primary DI / UDI-DI
- 09421031793791 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Preformed dental crown, permanent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
OVC Hybrid by Rhondium, Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Rhondium, Ltd.
Sources (1)
- FDA UDI 6fda885d-4ace-4d2c-94f0-e671e029fc56 38 fields · synced Jun 8, 2026