Duns Number:012430880
Device Description: AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, FOR REMOVA AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, FOR REMOVAL OF STAINS AND PLAQUE
Catalog Number
5703088
Brand Name
Henry Schein
Version/Model Number
5703088
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
EJR
Product Code Name
AGENT, POLISHING, ABRASIVE, ORAL CAVITY
Public Device Record Key
cf9e3ce2-cf94-4493-a364-7470d59ec579
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |