Duns Number:381582196
Device Description: CROWN EXTENSION KIT:Completely innocuous to the gingiva guaranteeing the integrity of bone CROWN EXTENSION KIT:Completely innocuous to the gingiva guaranteeing the integrity of bone and adjacent teeth. A tip for each stage: the instrument sequence adapts to the different surgical crown lengthening stages, starting from extensive bone remodeling up to precise osteotomy.
Catalog Number
F87554
Brand Name
ACTEON
Version/Model Number
KIT TIPS CE PZT 2
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
K091252
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
4b349b13-993a-4d87-b56d-205b10b0f527
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 |