Duns Number:316699578
Device Description: V-Print tray is a light-curing resin for the generative manufacture of individual trays, b V-Print tray is a light-curing resin for the generative manufacture of individual trays, base plates and occlusal registrations using CAD/CAM technology.
Catalog Number
6047
Brand Name
V-Print Tray
Version/Model Number
6047
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
8aa3c97b-544c-4e6f-b38d-37e8a2acb762
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 2020
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |