Duns Number:381582196
Device Description: Automatic power regulation and perfectly controlled vibrations with the NEWTRON® technolog Automatic power regulation and perfectly controlled vibrations with the NEWTRON® technologyIncreased tactile sense for the practitioner.
Catalog Number
F60216
Brand Name
ACTEON
Version/Model Number
NEWT BOOSTER US HP NEWT NO TIP
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
K131997
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
f63fb961-f194-4a9a-9b19-76b23bd31489
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |