Duns Number:101147171
Device Description: Flexi-Overdenture EZ-Change Intro Kit
Catalog Number
250-00
Brand Name
Flexi-Overdenture
Version/Model Number
250-00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIY
Product Code Name
INSTRUMENT, FILLING, PLASTIC, DENTAL
Public Device Record Key
a29de139-2fae-4208-86d9-78bff2b1b405
Public Version Date
July 20, 2020
Public Version Number
1
DI Record Publish Date
July 10, 2020
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 | 249 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 3 |