Duns Number:306155953
Device Description: The Elos Drill Extender is for extending tools with ISO 1797 connections. The device is ma The Elos Drill Extender is for extending tools with ISO 1797 connections. The device is made of stainless steel. The Elos Drill Extender design, finish and quality makes the tool well suited for extending a drill or dental tool and to placement and adjustment of implants, abutments and prosthetic screws. The Elos Drill Extender is easy to prepare for cleaning, disinfection and sterilization.
Catalog Number
-
Brand Name
Drill Extender
Version/Model Number
c7650
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
3e9d74e8-602e-46a6-943e-30e31f836c49
Public Version Date
March 19, 2020
Public Version Number
1
DI Record Publish Date
March 11, 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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |