Duns Number:300537672
Device Description: SET of total 8 pcs VENEERS (1x edelweiss VENEER 14 M, 1x edelweiss VENEER 13 M, 1x edelwe SET of total 8 pcs VENEERS (1x edelweiss VENEER 14 M, 1x edelweiss VENEER 13 M, 1x edelweiss VENEER 12 M, edelweiss VENEER 11 M, edelweiss VENEER 21 M, edelweiss VENEER 22 M, edelweiss VENEER 23 M and edelweiss VENEER 24 M)
Catalog Number
-
Brand Name
edelweiss VENEER SET 14-24 M up
Version/Model Number
13010
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
fa68ecca-731b-426f-9d46-cfdcf0e16bf4
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
August 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 |