Duns Number:306155953
Device Description: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the fi The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.
Catalog Number
-
Brand Name
Elos Accurate® Hexalobular Prosthetic Screw
Version/Model Number
AS-ATEM2008A-1
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
Yes
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
K191919
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
ac25bc7d-1260-4649-9127-dc20b5d522f9
Public Version Date
September 22, 2020
Public Version Number
2
DI Record Publish Date
March 31, 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 |