Identity
- Trade Name
- OVC™ One Visit Crown FDA UDI
- Generic Name
- Preformed dental crown, permanent FDA UDI
- Device Name
- The Starter Kit consists of a set of 40 OVCs in tooth shade A2 - one each for 8 tooth types, upper and lower molar and premolars, in five sizes for each tooth type individually packaged. Each OVC is packaged with 4 x OVC Wedges, a Selector Key and an OVC Replica. Each kit includes an accessory kit - a convenience kit for clinicians containing a procedural aids. FDA UDI
- Model / Reference
- OVC Starter Kit A2 US FDA UDI
- Description
- The Starter Kit consists of a set of 40 OVCs in tooth shade A2 - one each for 8 tooth types, upper and lower molar and premolars, in five sizes for each tooth type individually packaged. Each OVC is packaged with 4 x OVC Wedges, a Selector Key and an OVC Replica. Each kit includes an accessory kit - a convenience kit for clinicians containing a procedural aids. FDA UDI
Identifiers
- Catalog Number
- OVC Starter Kit A2 US FDA UDI
- Primary DI / UDI-DI
- 09421031790899 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
- 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
Yes
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™ One Visit Crown by Rhondium, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Rhondium, Ltd.
Sources (1)
- FDA UDI 7bb0b58c-2748-4b70-ad22-62423a7751f4 39 fields · synced Jun 8, 2026