Duns Number:083235549
Device Description: Henry Schein® Super Concentrated Tartar & Stain - Bottles (16 oz)
Catalog Number
1721368FG
Brand Name
Henry Schein® Super Concentrated Tartar & Stain
Version/Model Number
1721368FG
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)
Yes
Over the Counter (OTC)
-
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
88f1c4b5-a9d4-4de2-ae09-d43b093e78b8
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
September 21, 2016
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 | 123 |
2 | A medical device with a moderate to high risk that requires special controls. | 397 |
U | Unclassified | 2 |