Duns Number:898067533
Device Description: Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or in Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure.
Catalog Number
4000019289
Brand Name
Allcem Veneer APS
Version/Model Number
Trans 2.5g
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
K191389
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
14d9755e-3faa-4b3d-8028-89ea846be99f
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
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 |