Duns Number:341086190
Device Description: novo.lign P veneer posterior WL2 lower A10 6 parts (34,35,36/44,45,46) 1 Assortment
Catalog Number
VUWL2A10
Brand Name
novo.lign P veneer
Version/Model Number
VUWL2A10
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
18daebf5-df5b-43aa-82d3-1ff91dccea21
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
EBREVUWL2A109
Quantity per Package
1
Contains DI Package
EBREVUWL2A100
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 |