Anterior/Premolar Procedure Instrument GW-APM-TIXX

GUDID 00858395006196

The Anterior/Premolar Procedure Instrument, when used with the GentleWave Console, is intended to be used on the anterior or premolar 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 procedure site.

SONENDO, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006196
• NIH Device Record Key: 0891fb26-4231-49df-8779-46fea2a6aafd
• Commercial Distribution Discontinuation: 2017-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Anterior/Premolar Procedure Instrument
• Version Model Number: FG-003-00002
• Catalog Number: GW-APM-TIXX
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 1
• 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 Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006196 [Primary]

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: 3
• Public Version Date: 2019-05-17
• Device Publish Date: 2016-09-23

Devices Manufactured by SONENDO, INC.

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• 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