Identifiers
- 510(k) Number
- K130025 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 Endotherapy System is an ultrasonic dental device classified as a scaler, designed for endodontic treatment. It employs advanced endotherapy techniques to clean and disinfect the root canal system by targeting microscopic spaces within teeth, reducing the need for extensive mechanical instrumentation.
This system is intended for use in dental offices and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (regulation number 872.4850). It is supplied as a reusable device and is not indicated for MRI use. The system is authorized for dental specialty applications and includes multiple model references for regulatory tracking.
Frequently asked questions
What is the primary purpose of the Sonendo Endotherapy System in dental treatment?
The Sonendo Endotherapy System is designed as an ultrasonic dental scaler specifically for endodontic procedures. It uses advanced ultrasonic technology to clean and disinfect the root canal system by targeting microscopic spaces within teeth, reducing the need for extensive mechanical instrumentation during root canal treatments.
Is the Sonendo Endotherapy System intended for single-use or reusable applications?
The Sonendo Endotherapy System is supplied as a reusable device, meaning it is designed for repeated use in dental offices after proper cleaning and maintenance. This makes it a cost-effective solution for long-term clinical applications.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The Sonendo Endotherapy System received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device under regulation number 872.4850. This classification indicates it is subject to special controls to ensure its safety and effectiveness for dental use.
Are there multiple models or variations of the Sonendo Endotherapy System available?
Yes, the Sonendo Endotherapy System includes multiple model references for regulatory tracking, though the exact clinical variations or specifications are not detailed in the provided data. These references are used to identify different configurations or iterations of the device for compliance purposes.
Can the Sonendo Endotherapy System be used in an MRI environment?
No, the Sonendo Endotherapy System is explicitly stated as not intended for MRI use. This is important for clinical settings where MRI compatibility must be considered to avoid interference or safety risks.
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: Saving Teeth. Restoring Health. | Sonendo®, The GentleWave® System | Sonendo® Inc., The GentleWave® System by Sonendo®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130025 | Class II | Active |
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Manufacturer
- Manufacturer
- Sonendo, Inc.
Sources (1)
- FDA 510(k) K130025 24 fields · synced Sep 20, 2026