Duns Number:898067533
Device Description: Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in l Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments.
Catalog Number
4000019368
Brand Name
Opus Bulk Fill APS
Version/Model Number
A1 4g
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K190758
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
f7199294-d551-4d0a-aa58-10e0ea4e1a68
Public Version Date
September 11, 2020
Public Version Number
2
DI Record Publish Date
November 04, 2019
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |