Identifiers
- 510(k) Number
- K193274 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rodo Abutment System is a dental device used as a connector between an implant and a dental prosthesis. It provides support and stability for the restoration, ensuring proper alignment and function in dental implant procedures.
This system is supplied as a single-use device and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code NHA and is manufactured by Rodo Medical Inc. in San Jose, California.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193274 | Class II | Active |
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Manufacturer
- Manufacturer
- Rodo Medical, Inc.
Sources (1)
- FDA 510(k) K193274 24 fields · synced Sep 23, 2026