Duns Number:186285342
Device Description: Vinyl Polysiloxane Cartridges, FAST Set, Alginate Alternate, 1 X 380 ml cartridge, 1 Bayon Vinyl Polysiloxane Cartridges, FAST Set, Alginate Alternate, 1 X 380 ml cartridge, 1 Bayonet Ring, 10 Dynamic Mixing Tips
Catalog Number
-
Brand Name
MASTER-DENT
Version/Model Number
20-713
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041028
Product Code
-
Product Code Name
-
Public Device Record Key
5420cbaf-e3ae-4992-a299-8d40c042d8a7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |