Duns Number:316699578
Device Description: V-Print splint comfort is a light-curing resin for the generative manufacturing of thermof V-Print splint comfort is a light-curing resin for the generative manufacturing of thermoflexible splints (including therapeutic splints) as well as thermoflexible auxillary parts and functional parts for derntal diagnostics using CAD/CAM technology.
Catalog Number
6126
Brand Name
V-Print splint comfort
Version/Model Number
6126
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
cbd10997-0fc4-4259-b2ca-78739bcdda39
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
October 15, 2021
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 |