Duns Number:096010525
Device Description: Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementatio Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhesive. 6 gram Dual Barrel. Boxed.
Catalog Number
SFRC
Brand Name
Shatkin FIRST Resin Cement Self-Cure
Version/Model Number
SFRC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 05, 2018
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
K884081
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
0102f0c9-7810-4312-bfcf-88e9dd65287a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 31, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |