GentleWave Console

GUDID 00858395006226

The GentleWave Console is a semi-stationary unit designed to prepare and deliver a procedure fluid to the Anterior/Premolar or Molar Procedure Instruments. The Procedure Instruments are used to deliver the procedure fluid to the selected anterior or premolar tooth when used with the Anterior/Premolar Procedure Instrument and the selected molar tooth when used with the Molar Procedure Instrument.

SONENDO, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006226
• NIH Device Record Key: 6d49acc6-8d7a-463f-a827-d209cf3605d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleWave Console
• Version Model Number: FG-002-00001
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006226 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by SONENDO, INC.

• 00858395006776 - GentleWave G4 Console: 2023-07-19 GentleWave G4 Console
• 00858395006769 - GentleWave G4 Support Arm: 2023-05-04
• 00858395006783 - Posterior CleanFlow Procedure Instrument with Matrix: 2023-05-04 CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
• 00195893912278 - Posterior CleanFlow Procedure Instrument with Matrices: 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (Singles)
• 00858395006622 - GentleWave G4 Console: 2022-11-02
• 00858395006745 - Posterior Cleanflow Matrices: 2022-11-02 Posterior Cleanflow Matrices (10 Pack)
• 00858395006707 - Posterior CleanFlow Procedure Instrument with Matrices: 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (10-Pack)
• 00858395006646 - Premolar CrossFire Procedure Instrument with Matrix: 2020-10-28 Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on th