Duns Number:101147171
Device Description: Post Cement Paste/Paste Chemical Cure Natural Shade A3 Sample
Catalog Number
811-00
Brand Name
Ti-Core Sample Natural
Version/Model Number
811-00
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
K922251
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
5d1246f5-2227-4e0b-976c-944a1704a737
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 |