Duns Number:115545837
Device Description: 4.0mm Diameter Implant 11.0mm Length SB
Catalog Number
-
Brand Name
TITAN IMPLANTS, INC.
Version/Model Number
BC-4S11S
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
K042971
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
c3330790-973c-4b80-a323-12d341e71a88
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 03, 2016
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 | 374 |
2 | A medical device with a moderate to high risk that requires special controls. | 1073 |