Duns Number:316699578
Device Description: VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.
Catalog Number
6117
Brand Name
VisCalor
Version/Model Number
6117
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
K201307,K201307
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
4197913a-3b09-468d-8452-26199e9e6fa0
Public Version Date
July 30, 2020
Public Version Number
1
DI Record Publish Date
July 22, 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 |