Duns Number:009051723
Device Description: This easy to use flosser is ideal for people of all ages. Virtually eliminates the difficu This easy to use flosser is ideal for people of all ages. Virtually eliminates the difficulty and finger pain associated with the common method of flossing. Makes flossing fun and promotes good oral hygiene. Simply wind the floss into place and begin flossing. The floss is advanced at the push of a button. The flosser features a simple tension adjustment mechanism, a floss cutter, and floss spool eject button. Includes two 30 yard refill spools.
Catalog Number
22217
Brand Name
Ultimate Flosser (White Fork/White Body)
Version/Model Number
22217
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JES
Product Code Name
Floss, Dental
Public Device Record Key
0858bef4-2cb7-4319-a427-ed4de05f7898
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 26, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |