Identifiers
- 510(k) Number
- K211995 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Sonendo Filling Material 5C is a two-part, water-soluble, radiopaque acrylate resin used for permanent root canal obturation. It is substantially equivalent to the predicate device EndoREZ Dual Cure (K071106) and is classified as a resin for root canal filling under FDA product code KIF.
The device is supplied in plastic syringes with a mixer and dispensing tip, utilizing a chemical curing system to harden within the root canal. It is intended for use by dental professionals trained in endodontics within a clinical setting and has received FDA 510(k) clearance under K211995.
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: PDF August 27, 2021 Sonendo, Inc. Steve Ziemba Vice President, Regulatory ..., K211995 FDA 510(k) - Sonendo Filling Material 5C | Sonendo, Inc., Sonendo Filling Material 5C (K211995) — FDA 510(k) | Innolitics, K211995 FDA 510(k) - Sonendo Filling Material 5C | Sonendo, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211995 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonendo, Inc.
Sources (1)
- FDA 510(k) K211995 24 fields · synced Oct 1, 2026