Duns Number:316699578
Device Description: Eugenol-free temporary luting cement with calcium hydroxide.Semi-elastic properties for sa Eugenol-free temporary luting cement with calcium hydroxide.Semi-elastic properties for safe adhesion of the temporary.Calcium hydroxide: supports formation of secondary dentine and is bacteriostatic.Eugenol-free, thus low allergy potential.Ideal before adhesive luting with resin cements, because no inhibition of curing reaction of resin-based filling or luting materials.
Catalog Number
1078
Brand Name
Provicol
Version/Model Number
1078
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
689b6ec8-03a3-41ec-af38-d9fd434c37d7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |