Duns Number:067488114
Device Description: HYDROXYLINE TC (Tooth Color) - Calcium Hydroxide Cavity Liner is a thin 'varnish' film tha HYDROXYLINE TC (Tooth Color) - Calcium Hydroxide Cavity Liner is a thin 'varnish' film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and 'pulp' shock. HYDROXYLINE TC is a dentin colored film which maintains the composite resins' esthetics for thin Class V restorations.
Catalog Number
05-1500
Brand Name
Hydroxyline
Version/Model Number
Kit - TC
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
-
Product Code
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
495d4b44-044e-46e0-a46d-0d20433104d8
Public Version Date
March 29, 2018
Public Version Number
2
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 |