Duns Number:381582196
Device Description: This kit of instruments, adapted to the anatomical context, is intended for clinical acts This kit of instruments, adapted to the anatomical context, is intended for clinical acts such as extraction of wisdom teeth, fractured roots, impacted teeth and root section. The tip gently slips between the root and "gently". Micro-ultrasonic oscillations cause detachment of the ligament without damaging the surrounding soft tissue.
Catalog Number
F87540
Brand Name
ACTEON
Version/Model Number
PACK LC EXTRACTION PZT 2 LED
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
cee8aeb9-b5ec-4d8d-8d01-74c8ac9803cd
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 |