Duns Number:083235549
Device Description: Topex® Prophy Paste Cherry Coarse Cups - 24 Cartons of 200 Cups
Catalog Number
AD30001FG
Brand Name
Topex® Prophy Paste
Version/Model Number
AD30001FG
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
59cdae2a-0068-420a-a437-56df44547f7c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
D687AD30001FG2
Quantity per Package
24
Contains DI Package
D687AD30001FG1
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 | 123 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |
| U | Unclassified | 2 |