Duns Number:381582196
Device Description: The "PARO KIT" contents he micro tips H3, H4R and H4L with curette have shape double guid The "PARO KIT" contents he micro tips H3, H4R and H4L with curette have shape double guidingedges to remove calculus and deposits with no risk of damage toconnective fi bers. They are designed for deep and narrow pocketsdebridement.
Catalog Number
F00902
Brand Name
ACTEON
Version/Model Number
KIT PARO GII SS PAM
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
c729ec9f-f1bb-4ab8-9379-3c1084eef3b6
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 |