Identity
- Trade Name
- OVC3 Hybrid FDA UDI
- Generic Name
- Preformed dental crown, permanent FDA UDI
- Device Name
- Package contains an OVC Hybrid in Shade A2 for tooth number FDI 24.25 XL : USA 12-13 XL A2 (Extra-Large) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica FDA UDI
- Model / Reference
- OVC3 Hybrid FDI 24.25 XL : USA 12-13 XL A2 FDA UDI
- Description
- Package contains an OVC Hybrid in Shade A2 for tooth number FDI 24.25 XL : USA 12-13 XL A2 (Extra-Large) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica FDA UDI
Identifiers
- Catalog Number
- 9421031796297 FDA UDI
- Primary DI / UDI-DI
- 09421031796297 FDA UDI
- 510(k) Number
- K143694 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
- 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
Category: Preformed dental crown, permanent
OVC3 Hybrid by Rhondium, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143694 also covers:
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
- OVC3 Hybrid — Rhondium, Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rhondium, Ltd.
Sources (1)
- FDA UDI f61ffec3-3721-460c-929a-c00918db5489 38 fields · synced May 30, 2026