Duns Number:381582196
Device Description: The hydrodynamic sinus lift technique by the crestal approach.The diamond-coated tips, of The hydrodynamic sinus lift technique by the crestal approach.The diamond-coated tips, of increasingdiameters (from 1.35mm to 2.80mm), aredesigned to drill and widen gradually theaccess canal to the Schneider membrane.The sterile spray cools down the tips to avoid any rise in temperature, whichcould lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation.
Catalog Number
F87536
Brand Name
ACTEON
Version/Model Number
SL INTRALIFT KIT PZT2
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
b90fa2ab-11e3-4c85-aa17-1ead1c2a482e
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 |