Duns Number:514891048
Device Description: ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, i ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
Catalog Number
7290112451675
Brand Name
Silk'n
Version/Model Number
ToothWave US
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN190039,DEN190039,DEN190039
Product Code
QMJ
Product Code Name
Powered Radiofrequency Toothbrush
Public Device Record Key
222f7018-2561-4033-b14a-ccddabb64f1f
Public Version Date
May 27, 2021
Public Version Number
1
DI Record Publish Date
May 19, 2021
Package DI Number
27290112451679
Quantity per Package
6
Contains DI Package
17290112451672
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |