Duns Number:316699578
Device Description: Dual-curing universal composite-based luting system.For all materials (metal, composite in Dual-curing universal composite-based luting system.For all materials (metal, composite inlays and ceramic, also zirconium dioxide).Bubble-free perfect mixing.Direct application.Excellent adhesion to dentine, enamel and to metals.Special one-step Ceramic bond for optimal adhesion to porcelain.Radiopaque.Available in three shadese.Try-In pastes simplify shade selection before cementation.All-in-one set.
Catalog Number
1217
Brand Name
Bifix QM
Version/Model Number
1217
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
06f0eea2-4f8a-4599-8626-0efca895b6a3
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 |