Duns Number:060272465
Device Description: Efferdent Coffee & Tea Anti Bacterial Denture Cleanser 126 CT Tab 6
Catalog Number
-
Brand Name
Efferdent
Version/Model Number
10814832010079
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFT
Product Code Name
Cleanser, Denture, Over The Counter
Public Device Record Key
e97de02b-2796-4ee4-a1c9-0af9e38d7631
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 2020
Package DI Number
10814832010079
Quantity per Package
1
Contains DI Package
00814832010072
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Single
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 14 |