Identifiers
- 510(k) Number
- K162677 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The L- OVC is a dental device intended for the restoration of permanent teeth with a single unit crown. It functions as a restorative solution for clinical dental applications.
This device is identified under FDA 510(k) number K162677. It is manufactured by Rhondium, Ltd. and is classified under product code EIH.
Frequently asked questions
What is the primary clinical application of the L- OVC?
The L- OVC is specifically intended for use in dental procedures to restore permanent teeth. It functions as a restorative solution for patients requiring a single unit crown.
Is the L- OVC a cleared medical device?
Yes, the L- OVC is a dental device that has received FDA 510(k) clearance under the number K162677. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the L- OVC?
The L- OVC is manufactured by Rhondium, Ltd., a company based in Katikati, New Zealand. The device is classified under the dental product code EIH.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rhondium Dental, PDF Microsoft Word - Rev2 L-OVC 510k Summary.doc, L- OVC (K162677) — FDA 510 (k) | Innolitics, L- OVC 510 (k) K162677 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162677 | Class II | Active |
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Manufacturer
- Manufacturer
- Rhondium, Ltd.
Sources (1)
- FDA 510(k) K162677 24 fields · synced Sep 21, 2026