SoundSeal GW-SYS-SOSE

GUDID 00858395006356

Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedures. Block-out resin: SoundSeal is used to block out undercuts and gingival embrasures prior to taking impressions for crowns and bridges. Sandblasting: SoundSeal is used to mask and protect the gingiva during sandblasting. It is also placed on the areas of teeth to be masked during the sandblasting process.

SONENDO, INC.

Rubber dam, non-latex

• Primary Device ID: 00858395006356
• NIH Device Record Key: 02c3e420-a16a-4966-a45b-735010c65aff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoundSeal
• Version Model Number: FG-008-00002
• Catalog Number: GW-SYS-SOSE
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006356 [Primary]
GS1	00858395006363 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022522

FDA Product Code

• EIE: Dam, Rubber

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-16

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