Duns Number:083235549
Device Description: Smart Pwares Prophy Paste Mint X-Coarse - Box of 200
Catalog Number
0830042FG
Brand Name
SmartPractice® Wares
Version/Model Number
0830042FG
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
Yes
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
EJR
Product Code Name
AGENT, POLISHING, ABRASIVE, ORAL CAVITY
Public Device Record Key
4876d3fd-b538-4ed4-91c2-9eb5009ea808
Public Version Date
March 29, 2018
Public Version Number
2
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 |