Duns Number:448015938
Device Description: Tetric Prime Refill 1x3g A2, Tetric Prime Refill 1x3g A2 Dentin, Tetric EvoFlow Refill 1x2 Tetric Prime Refill 1x3g A2, Tetric Prime Refill 1x3g A2 Dentin, Tetric EvoFlow Refill 1x2g A3, Tetric PowerFill Ref. 1x3g IVA, Tetric PowerFlow Refill 1 x 2g IVA, AdheSE Universal 0.5ml VivaPen (BULK)
Catalog Number
706565WW
Brand Name
Tetric Prime
Version/Model Number
706565WW
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
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
72b32223-5331-4d99-8ccd-4224a2ef9260
Public Version Date
August 05, 2020
Public Version Number
1
DI Record Publish Date
July 28, 2020
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 |