Duns Number:381582196
Device Description: The AS9D tip is for complex cases and allowspreparation of the root canal up to the corona The AS9D tip is for complex cases and allowspreparation of the root canal up to the coronalthird. The diamond coating of the AS9D is onlypresent on the extremity of the instrumentnot to over-prepare the canal.
Catalog Number
F00067
Brand Name
ACTEON
Version/Model Number
TIP AS9D
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
de16651f-99cc-4ea1-864b-edb547b28973
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 |