Duns Number:381582196
Device Description: The perfectly-controlled vibrations and high-quality tips bring to treatments more preserv The perfectly-controlled vibrations and high-quality tips bring to treatments more preservation, efficacy and comfort.An optimized external irrigation system with graduated tanks allowing to use any type of irrigant and to fill in during procéduresTreatments guided in real time with B.LED technology which simultaneously reveals and remove dental plaque
Catalog Number
F62107
Brand Name
ACTEON
Version/Model Number
NEWTRON P5 XS B LED CBVS
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
000540f9-5ce9-45e1-bae2-50c46b23b1bc
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 |