Duns Number:448015938
Device Description: Variolink Esthetic DC Light, Neutral, Warm, Variolink Esthetic Try-In Paste Light, Neutral Variolink Esthetic DC Light, Neutral, Warm, Variolink Esthetic Try-In Paste Light, Neutral, Warm, Total Etch, Adhese Universal VivaPen, Monobond Plus, Liquid Strip, Optra Stick Test Pack, Cannulas Total Etch / Liquid Strip, VivaPen Brush Cannulas, VivaPen Protective Sleeve, Mixing Tips, Applicaiton Tips Variolink, Brush holder, Brushes, soft, various accessories
Catalog Number
666434WW
Brand Name
Variolink Esthetic
Version/Model Number
666434WW
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
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
19449807-36f6-44a5-8b8d-8eb8e398f473
Public Version Date
February 01, 2019
Public Version Number
2
DI Record Publish Date
September 27, 2018
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 | 131 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12768 |