Duns Number:898067533
Device Description: Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up.
Catalog Number
4000019280
Brand Name
Allcem Core
Version/Model Number
A1 6g
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
100621b2-0ea0-430e-ae27-a6698e4339da
Public Version Date
November 08, 2021
Public Version Number
3
DI Record Publish Date
December 02, 2019
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |