Duns Number:828894373
Device Description: The GentleWave Console is a semi-stationary unit designed to prepare and deliver a procedu The GentleWave Console is a semi-stationary unit designed to prepare and deliver a procedure fluid to the Anterior/Premolar or Molar Procedure Instruments. The Procedure Instruments are used to deliver the procedure fluid to the selected anterior or premolar tooth when used with the Anterior/Premolar Procedure Instrument and the selected molar tooth when used with the Molar Procedure Instrument.
Catalog Number
-
Brand Name
GentleWave Console
Version/Model Number
FG-002-00001
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
-
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
6d49acc6-8d7a-463f-a827-d209cf3605d9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
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 |