Molar Procedure Instrument with Accessories - The Molar Procedure Instrument with Accessories, - SONENDO, INC.

Duns Number:828894373

Device Description: The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Con 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.

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More Product Details

Catalog Number

GW-MOL-PI10

Brand Name

Molar Procedure Instrument with Accessories

Version/Model Number

FG-001-00025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Device Record Status

Public Device Record Key

03347154-7115-4d53-bf3a-90d2c0a7654d

Public Version Date

April 30, 2018

Public Version Number

1

DI Record Publish Date

March 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONENDO, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 10