Duns Number:448037775
Device Description: Vision-Zirkon Gingiva Softred 50g
Catalog Number
2241
Brand Name
Vision-Zirkon
Version/Model Number
2241
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
-
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
K990790
Product Code
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
1c9236a5-8ad6-428b-828e-14a4587f99f0
Public Version Date
November 04, 2019
Public Version Number
3
DI Record Publish Date
November 20, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 948 |