Identifiers
- 510(k) Number
- K190359 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sonendo GentleWave System is a dental device classified as a scaler, ultrasonic. It is designed for use in dental procedures to perform scaling functions.
The device is manufactured by Sonendo, Inc. and received FDA 510(k) clearance with the K number K190359 on March 16, 2019. It is registered under multiple registration numbers and falls under product code ELC with regulation number 872.4850. The device is intended for dental use as indicated by its advisory committee classification.
Frequently asked questions
What is the Sonendo GentleWave System used for?
The Sonendo GentleWave System is an ultrasonic dental scaler designed for use in dental procedures to perform scaling functions. It is manufactured by Sonendo, Inc. and received FDA 510(k) clearance on March 16, 2019.
What is the regulatory status of the GentleWave System?
The Sonendo GentleWave System has received FDA 510(k) clearance with K number K190359 on March 16, 2019. It is classified under product code ELC with regulation number 872.4850 and is intended for dental use as indicated by its advisory committee classification.
Is the GentleWave System reusable or single-use?
The device data does not specify whether the GentleWave System is reusable or single-use. For information regarding reuse or disposal, please consult the manufacturer's instructions or contact Sonendo, Inc. directly.
What sizes or models of the GentleWave System are available?
The device data does not provide information about different sizes or models of the GentleWave System. For specific product variations, please contact Sonendo, Inc. or refer to their product documentation.
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 | K190359 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonendo, Inc.
Sources (1)
- FDA 510(k) K190359 24 fields · synced Sep 23, 2026