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 ID00858395006356
NIH Device Record Key02c3e420-a16a-4966-a45b-735010c65aff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoundSeal
Version Model NumberFG-008-00002
Catalog NumberGW-SYS-SOSE
Company DUNS828894373
Company NameSONENDO, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8447663636
Emailinfo@sonendo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006356 [Primary]
GS100858395006363 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIEDam, Rubber

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-16

Devices Manufactured by SONENDO, INC.

00858395006776 - GentleWave G4 Console2023-07-19 GentleWave G4 Console
00858395006769 - GentleWave G4 Support Arm2023-05-04
00858395006783 - Posterior CleanFlow Procedure Instrument with Matrix2023-05-04 CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
00195893912278 - Posterior CleanFlow Procedure Instrument with Matrices2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (Singles)
00858395006622 - GentleWave G4 Console2022-11-02
00858395006745 - Posterior Cleanflow Matrices2022-11-02 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 Matrix2020-10-28 Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on th

Trademark Results [SoundSeal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOUNDSEAL
SOUNDSEAL
98763579 not registered Live/Pending
Yang, Tan
2024-09-23
SOUNDSEAL
SOUNDSEAL
97700519 not registered Live/Pending
Illinois Tool Works Inc.
2022-12-01
SOUNDSEAL
SOUNDSEAL
87797964 5724897 Live/Registered
Sonendo, Inc.
2018-02-14
SOUNDSEAL
SOUNDSEAL
87797947 not registered Live/Pending
Sonendo, Inc.
2018-02-14
SOUNDSEAL
SOUNDSEAL
87574881 5432253 Live/Registered
Innate Devices, LLC
2017-08-18
SOUNDSEAL
SOUNDSEAL
78615831 3357228 Live/Registered
Emerson Electric Co.
2005-04-25
SOUNDSEAL
SOUNDSEAL
78354548 not registered Dead/Abandoned
Therus Corporation
2004-01-20

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