Duns Number:316699578
Device Description: V-Print splint is a light-curing resin for the generative manufacture of therapeutic splin V-Print splint is a light-curing resin for the generative manufacture of therapeutic splints as well as splints, auxiliary parts and functional parts for dental diagnostics using CAD/CAM technology.
Catalog Number
6044
Brand Name
V-Print splint
Version/Model Number
6044
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
MQC
Product Code Name
Mouthguard, Prescription
Public Device Record Key
799ed175-8867-43d5-9b29-3ccfc9466649
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
November 12, 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 |