Duns Number:306155953
Device Description: A driver for a dental torque wrench for placement and adjustment of dental implants, abutm A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Catalog Number
-
Brand Name
Elos Driver
Version/Model Number
C19356
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2022
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
8954a7fb-4e47-4c23-980b-e2fb04ec1352
Public Version Date
January 10, 2022
Public Version Number
3
DI Record Publish Date
March 23, 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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |