Duns Number:898067533
Device Description: Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provi Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.
Catalog Number
4000055051
Brand Name
Allcem Veneer Try-in
Version/Model Number
A3 2g
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
93111895-2bc5-4504-802d-4cafc957abfc
Public Version Date
September 16, 2020
Public Version Number
3
DI Record Publish Date
May 31, 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 |