Anterior/Premolar Procedure Instrument GW-APM-TIXX

GUDID 00858395006196

The Anterior/Premolar Procedure Instrument, when used with the GentleWave Console, is intended to be used on the anterior or premolar 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 procedure site.

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006196
NIH Device Record Key0891fb26-4231-49df-8779-46fea2a6aafd
Commercial Distribution Discontinuation2017-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnterior/Premolar Procedure Instrument
Version Model NumberFG-003-00002
Catalog NumberGW-APM-TIXX
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

Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006196 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-17
Device Publish Date2016-09-23

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.