Duns Number:119193803
Device Description: Medium Grit Mint Prophy Paste with added TCP
Catalog Number
-
Brand Name
PractiPro Mint TCP Prophy Paste Medium
Version/Model Number
7159810 MED
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062166,K062166
Product Code
EJR
Product Code Name
Agent, Polishing, Abrasive, Oral Cavity
Public Device Record Key
e8dab878-8267-4a16-bbc1-799aa9690823
Public Version Date
June 06, 2022
Public Version Number
1
DI Record Publish Date
May 27, 2022
Package DI Number
00723896021248
Quantity per Package
5
Contains DI Package
00723896008591
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 | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |