Duns Number:828894373
Device Description: The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended 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.
Catalog Number
GW-MOL-PI01
Brand Name
Molar Procedure Instrument with Accessories
Version/Model Number
FG-001-00022
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
0a9f96dd-11ec-434e-a8b4-5120d86181ab
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |