Duns Number:316133664
Device Description: Double-curing, free-flowing, radiopaque composite material that is used to build the core Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
Catalog Number
75200
Brand Name
BISICO Repo-Core DC A3 Mini
Version/Model Number
75200
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
K984097
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
1c402864-90ae-49d6-b6a5-2d57b4a45b3a
Public Version Date
June 29, 2020
Public Version Number
2
DI Record Publish Date
June 18, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |