Duns Number:439240722
Device Description: It is connected at the tail to the contra-angle handpiece screwdriver shaft and allows it It is connected at the tail to the contra-angle handpiece screwdriver shaft and allows it to be used either manually or with a torque ratchet.
Catalog Number
760ACC
Brand Name
OT EQUATOR-OT BRIDGE
Version/Model Number
ADAPTER FOR SCREWDRIVER/STEM
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
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
7b195477-c537-42ce-a0b9-21389c76d961
Public Version Date
February 22, 2021
Public Version Number
2
DI Record Publish Date
October 21, 2020
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 | 1269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1987 |