Duns Number:006309355
Device Description: First Choice Prophy Gems Prophy Paste, Fluoride, Coarse Grit, 2 g, Cool Mint
Catalog Number
PGC103CM
Brand Name
Biotrol
Version/Model Number
PGC103CM
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)
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
c6e4be80-b8b0-41ce-a6c2-8233a24fa275
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
20302730000119
Quantity per Package
12
Contains DI Package
00302730000115
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 | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |