Duns Number:381582196
Device Description: The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Peri The SP Newtron module is a multi-clinic piezo-ultrasonic unit that drives four modes (Perio, Endo, Scaling and "Boost")
Catalog Number
X55287
Brand Name
ACTEON
Version/Model Number
SP NEWT 4K3,7V V3 ADEC CTRL
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
628ded4f-7a33-470f-9e97-232f669efbc0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |