Duns Number:316133664
Device Description: Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of cr Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.
Catalog Number
75240
Brand Name
BISICO Cem DC A3
Version/Model Number
75240
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
K990108
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
b2988d91-3e04-47e8-a64e-0b5a450d96a6
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 |