Duns Number:148312838
Device Description: Alpha-Dent® Alginate Flavorings (Watermelon) add a unique and pleasant flavor to each algi Alpha-Dent® Alginate Flavorings (Watermelon) add a unique and pleasant flavor to each alginate mixture. The fun flavors provide patients with a wide choice, making impression taking experience more enjoyable. Simple to use, just add 5 to 7 drops for every scoop of powder. The bottle contains 2 fl. oz. (59.2ml).
Catalog Number
620.2102.001
Brand Name
Alpha-Dent® Alginate Flavorings
Version/Model Number
620.2102.001
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
K940120
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
069c763a-fd5f-42d3-8a38-aeb024b0910d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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. | 183 |