Duns Number:067488114
Device Description: Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seam Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless compatibility to other restorative materials. Ca-Lok™ is radiopaque and releases fluoride.Ca-Lok™ is used as a protective liner with adhesion, which can be placed under restorative materials and cements for many types of cavity preparations. With its flowable viscosity and unique handling characteristics, precise placement and control is achieved.
Catalog Number
05-7000
Brand Name
Ca-Lok - Calcium Base / Liner
Version/Model Number
Kit - 1.8 gm Syr 2 pk
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153191
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
fda0b041-5168-4be5-9b1d-285b8f7aae5c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |