Duns Number:300537672
Device Description: Toolbox with content 20 Veneers (1x Veneer Set 13-23 S up, 1x Veneer Set 14-24 M up, 1x Ve Toolbox with content 20 Veneers (1x Veneer Set 13-23 S up, 1x Veneer Set 14-24 M up, 1x Veneer Set 13-23 L up), 20x Composite tips (each 5 pcs of A0, A1, A2 and Enamel), 1x Veneer Bond bottle + Accessoires
Catalog Number
-
Brand Name
edelweiss VENEER KIT
Version/Model Number
17100
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
Yes
Prescription Use (Rx)
-
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
0352a426-3d8f-41c4-bca2-ea84137aaad3
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
November 28, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 145 |