Duns Number:320744915
Device Description: Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 3 Syringes @ 4 g Light-curing, radiopaque Bulk Fill. Quality fillings in no time. Content: 3 Syringes @ 4 g in the shades Universal (2 x), Light (1 x), 1 bottle @ 5 ml of Ecosite Bond.
Catalog Number
220750
Brand Name
Ecosite Bulk Fill
Version/Model Number
220750
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
K171772,K171772
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
2b9bca9f-259d-499a-b7c4-7a546d768570
Public Version Date
July 08, 2019
Public Version Number
1
DI Record Publish Date
June 30, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |