Molar Procedure Instrument with Accessories GW-MOL-PI01

GUDID 00858395006325

The Molar Procedure Instrument, 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 ID00858395006325
NIH Device Record Keyd42d836e-097d-4040-93fe-5c25265a19cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMolar Procedure Instrument with Accessories
Version Model NumberFG-001-00023
Catalog NumberGW-MOL-PI01
Company DUNS828894373
Company NameSONENDO, INC.
Device Count1
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 HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006325 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-30
Device Publish Date2018-03-28

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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