GentleWave G4 Support Arm GW-ARM-0001

GUDID 00858395006769

SONENDO, INC.

Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006769
• NIH Device Record Key: 49ec3041-0415-4b09-99b4-13f2f1e0a5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleWave G4 Support Arm
• Version Model Number: FG-012-00002
• Catalog Number: GW-ARM-0001
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com
• Phone: 8447663636
• Email: info@sonendo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006769 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-04
• Device Publish Date: 2023-04-26

Devices Manufactured by SONENDO, INC.

• 00858395006776 - GentleWave G4 Console: 2023-07-19 GentleWave G4 Console
• 00858395006769 - GentleWave G4 Support Arm: 2023-05-04
• 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