Duns Number:113170088
Device Description: Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. Crown Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok Kit contains (4) 6gm Screw Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch. Crown Lok is a self-curing two minute working time fluoride releasing cement.
Catalog Number
CL
Brand Name
Crown-Lok
Version/Model Number
CL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2017
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
461f29cf-d41a-46c4-9b0e-07c8e634adae
Public Version Date
July 24, 2018
Public Version Number
3
DI Record Publish Date
July 25, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |