Duns Number:381582196
Device Description: The tips (H3, H4L/R) used with a push stroke without scraping are designed for :- sub-ging The tips (H3, H4L/R) used with a push stroke without scraping are designed for :- sub-gingival scaling, - non-surgical treatment of deepand narrow pockets (>4-6mm), - open treatments (flap surgery). Diamond-coated tips (H1, H2L/R), used in the second step, are designed to remove calculus from very narrow inter-root spaces and furcations. They are used with very low pressure and are also recommended for the debridement of periodontal abscesses and for odontoplasty during non-surgical treatment.
Catalog Number
F87321
Brand Name
ACTEON
Version/Model Number
KIT NEWTRON PARO
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
K132322
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
90de375c-390d-474f-a5a3-4adcaa14cb8c
Public Version Date
July 06, 2018
Public Version Number
3
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 |