Duns Number:480082080
Device Description: Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupli Turbine type high- speed handpiece. Unit supplied by a hose, via a special ISO 9168 coupling. Anti- heat push- button bur changing mechanism. Ceramic ball bearings, 4 sprays. Optical glass rod with light.
Catalog Number
1601152-001
Brand Name
TU Bora 2 LED
Version/Model Number
1601152-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
c84219be-ec97-4215-bc77-5f351da9c974
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
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 | 213 |