Duns Number:101147171
Device Description: Core Material and Post Cement Syrangeable Dual Cure Natural Shade A2 Sample
Catalog Number
832-01
Brand Name
Ti-Core Flow Plus Sample
Version/Model Number
832-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101504
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
bfe67b70-c27d-48a8-b8da-499a91c94f5d
Public Version Date
October 26, 2022
Public Version Number
4
DI Record Publish Date
July 01, 2016
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 | 249 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 3 |