Duns Number:078352849
Device Description: Screw Dental Implant 8.0mm in diameter and 17mm in length
Catalog Number
IS8.0x17
Brand Name
TatumSurgical/Screw Implant
Version/Model Number
Screw/8.0 x 17
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 29, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K811923
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
cd48224f-eb76-41ec-a27a-d49e5e64bb08
Public Version Date
June 01, 2020
Public Version Number
4
DI Record Publish Date
October 30, 2015
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |