Duns Number:341553293
Device Description: Universal light cure nano-hybrid composite for restorations. The kit contains different sh Universal light cure nano-hybrid composite for restorations. The kit contains different shades of Harvard PremiumFill.
Catalog Number
-
Brand Name
Harvard PremiumFill Kit A1; A2; A3; A3,5; B2; A2opaque, Incisal
Version/Model Number
7082210
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
71140d05-10c7-427f-ace0-4ba5c10087e0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 21, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |