SoundSeal

Basic Information

• Brand Name: SoundSeal
• Primary DI: 00858395006356
• Version / Model: FG-008-00002
• Catalog Number: GW-SYS-SOSE
• Company Name: SONENDO, INC.
• Labeler DUNS: 828894373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-01-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 02c3e420-a16a-4966-a45b-735010c65aff

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIE	Dam, Rubber	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45004	Rubber dam, non-latex	A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858395006356	GS1
Unit of Use	00858395006363	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K022522	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius