Duns Number:381582196
Device Description: For less traumatic bone surgery,Comprising six ultrasonic tips (three saws and three scalp For less traumatic bone surgery,Comprising six ultrasonic tips (three saws and three scalpels) adapted to the different cases that arise in the intra-oral environment, the BS Kitis used for clinical treatments such as:- bone harvesting, - osteoplasty, - crest expansion, - preparation of the implant site, - accessing the lower alveolar nerve.
Catalog Number
F87509
Brand Name
ACTEON
Version/Model Number
KIT INSERT BS PZT II
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
5a527fca-2c4b-4567-8429-b2136751a1f9
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 |