Duns Number:008124539
Device Description: 2 oz. tube
Catalog Number
-
Brand Name
Dyna Care Denture Adhesive
Version/Model Number
4865
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
-
Product Code
KOO
Product Code Name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Public Device Record Key
d88e4855-927f-4166-9d78-d93e6662260f
Public Version Date
August 23, 2022
Public Version Number
1
DI Record Publish Date
August 15, 2022
Package DI Number
00616784486536
Quantity per Package
72
Contains DI Package
00616784486512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |