Sonendo Gentle Wave System

• K Number: K153157
• Device Name: Sonendo Gentle Wave System
• Manufacturer: SONENDO, INC.
• Date Cleared: 2016-01-29 ( 88 days)
• Product Code: ELC
• Regulation Number: 872.4850
• Type: Special
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar HandPiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Sonendo GentleWave™ System, confirming its substantial equivalence to a predicate device and outlining its indications for use. It does not include data from performance studies.

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.