Duns Number:341086190
Device Description: novo.lign P veneer posterior WL3 lower A30 6 parts (34,35,36/44,45,46) 1 Assortment
Catalog Number
VUWL3A30
Brand Name
novo.lign P veneer
Version/Model Number
VUWL3A30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
ELM
Product Code Name
Denture, plastic, teeth
Public Device Record Key
c1c20eb8-459c-4986-b7bf-821ec8fb7ae5
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
EBREVUWL3A309
Quantity per Package
1
Contains DI Package
EBREVUWL3A300
Package Discontinue Date
September 21, 2016
Package Status
Not in Commercial Distribution
Package Type
dummy
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 375 |