Molar Procedure Instrument with Accessories GW-MOL-PI10

GUDID 00858395006257

The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.

SONENDO, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006257
• NIH Device Record Key: 6d46c986-0479-4aef-acc3-5a4f976982db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Molar Procedure Instrument with Accessories
• Version Model Number: FG-001-00020
• Catalog Number: GW-MOL-PI10
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8447663636
• Email: info@sonendo.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 69.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69.7 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 69.7 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006257 [Primary]
GS1	00858395006264 [Unit of Use]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-28

On-Brand Devices [Molar Procedure Instrument with Accessories]

• 00858395006332: The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console,
• 00858395006325: The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be
• 00858395006257: The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console,
• 00858395006189: The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be