Duns Number:847905890
Device Description: Volume - Impression Material - Rigid Tray - Super Fast Set - 2 Hard Cartridges (380 ml eac Volume - Impression Material - Rigid Tray - Super Fast Set - 2 Hard Cartridges (380 ml each)
Catalog Number
-
Brand Name
Take 1 Advanced
Version/Model Number
34826
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
621c1704-be38-4a56-ba1b-d9fd730cc038
Public Version Date
March 16, 2020
Public Version Number
4
DI Record Publish Date
August 31, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| U | Unclassified | 1 |