Duns Number:119193803
Device Description: Innovative SmileGoods Sponge Dental Floss expands in contact with saliva to clean wider sp Innovative SmileGoods Sponge Dental Floss expands in contact with saliva to clean wider spaces more effectively. Contains beneficial xylitol for added defense against interproximal bacteria and plaque. Pocket-sized dispenser holds 12 yards of floss. 72 dispensers per case. Mint flavored.
Catalog Number
70-45200
Brand Name
Smilegoods Sponge Dental Floss Mint Xylitol
Version/Model Number
FL-1553
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
Yes
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
b00d0bb3-1dff-4719-a18f-68bd7b626d48
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010181
Quantity per Package
16
Contains DI Package
00723896010174
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |