Duns Number:113170088
Device Description: Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. C Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok is a self-curing two minute working time fluoride releasing cement. This is 6gm Screw Blue Paste A Syringe
Catalog Number
CLSAB
Brand Name
CrownLok
Version/Model Number
CLSAB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
6b7af24b-2686-4315-8080-8696b0161dbf
Public Version Date
October 29, 2018
Public Version Number
5
DI Record Publish Date
September 03, 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 |