Molar Procedure Instrument with Accessories GW-MOL-PI10

GUDID 00858395006257

The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar 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 treatment site.

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006257
NIH Device Record Key6d46c986-0479-4aef-acc3-5a4f976982db
Commercial Distribution StatusIn Commercial Distribution
Brand NameMolar Procedure Instrument with Accessories
Version Model NumberFG-001-00020
Catalog NumberGW-MOL-PI10
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

Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 69.7 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006257 [Primary]
GS100858395006264 [Unit of Use]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-28

On-Brand Devices [Molar Procedure Instrument with Accessories]

00858395006332The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console,
00858395006325The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be
00858395006257The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console,
00858395006189The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be

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