Duns Number:067488114
Device Description: ZERO-G™ is a dual-cure implant cement and is recommended for intermediate to long-term cem ZERO-G™ is a dual-cure implant cement and is recommended for intermediate to long-term cementation of implant-retained restorations. Retrievable, easy to see, simple removal of excess cement.
Catalog Number
46-5000
Brand Name
ZERO-G Bio Implant Cement
Version/Model Number
3.5 gm Syringe - Evaluator
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141503
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
fc0e4161-7e69-4189-b92e-49d393bb8f3b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |