Duns Number:341086190
Device Description: novo.lign P veneer posterior 1G3 upper A10 4 parts (14,15,16,17) 1 Assortment
Catalog Number
VO1G3A10
Brand Name
visio.lign system
Version/Model Number
novo.lign
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
Yes
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
e01df5bc-7ef1-46db-9e34-10259ad2fff3
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 06, 2016
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 375 |