Duns Number:137217043
Device Description: Alginate Alternative is an addition cured elastomeric vinyl impression material specifical Alginate Alternative is an addition cured elastomeric vinyl impression material specifically formulated to be used as an alternative to traditional alginate materials. Intended to be used primarily for taking impressions for case study models, temporary crown and bridge fabrication, partial denture impression, Orthodontic models and counter impressions .Alginate Alternative is a non-toxic material that, when set, is chemically resistant. For SDS and instructions for use visit https://www.scottsdental.com/impression-material/alginate-substitutes/standby-alginate-alternative.html
Catalog Number
104-6301
Brand Name
STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk
Version/Model Number
104-6301
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"
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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
-
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
eb00ad13-6a8d-4acb-8cb7-212947f606a4
Public Version Date
August 26, 2020
Public Version Number
3
DI Record Publish Date
October 25, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1050 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |