Duns Number:083235549
Device Description: Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartrid Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartridge Standard Pack
Catalog Number
61E810
Brand Name
Algin-X™ Ultra DECA™
Version/Model Number
61E810
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
-
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
6d721d11-1ae4-4264-a5cc-de3991ad7f53
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
D00261E81082
Quantity per Package
3
Contains DI Package
D00261E8101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 123 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |
| U | Unclassified | 2 |