Duns Number:012072823
Device Description: For restoring the original smoothness and polishing of dental porcelain crowns, inlays, o For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use.
Catalog Number
-
Brand Name
TEMREX SATIN POLISHING PASTE
Version/Model Number
5200, 5210
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K852157
Product Code
EJR
Product Code Name
Agent, Polishing, Abrasive, Oral Cavity
Public Device Record Key
fd94fb4d-1e36-40f5-8e5c-33f27ca93deb
Public Version Date
March 17, 2022
Public Version Number
1
DI Record Publish Date
March 09, 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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |