Duns Number:448015938
Device Description: Tetric CAD for CEREC HT I12 A1, Tetric CAD for CEREC HT I12 A2, Tetric CAD for CEREC HT I1 Tetric CAD for CEREC HT I12 A1, Tetric CAD for CEREC HT I12 A2, Tetric CAD for CEREC HT I12 A3, Tetric CAD for CEREC MT C14 A1, Tetric CAD for CEREC MT C14 A2, Tetric CAD for CEREC MT C14 A3, Variolink Esthetic DC Neutral, Adhese Universal VivaPen, OptraPol Test Pack, various accessories
Catalog Number
692157EN
Brand Name
Tetric
Version/Model Number
692157EN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 23, 2022
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
88b5b524-19c1-47e2-970e-8adf3491363a
Public Version Date
June 24, 2022
Public Version Number
4
DI Record Publish Date
September 27, 2018
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 |