Duns Number:448015938
Device Description: Tetric Prime Refill 10x0.25g A2, Tetric Prime Refill 10x0.25 T, Cavifil Injector Refill Re Tetric Prime Refill 10x0.25g A2, Tetric Prime Refill 10x0.25 T, Cavifil Injector Refill Redesign, OptraGloss Test Pack 2
Catalog Number
745236WW
Brand Name
Tetric Prime
Version/Model Number
745236WW
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
-
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
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
78f31c28-8ff1-47f2-ab04-91240bac7179
Public Version Date
February 19, 2021
Public Version Number
1
DI Record Publish Date
February 11, 2021
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 | 131 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12768 |