Duns Number:315830349
Device Description: Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass f Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre.
Catalog Number
-
Brand Name
Capo Hybrid B 2, 5 g
Version/Model Number
232024
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
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
8080d881-073a-4d8d-a3f6-df784adb883f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 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. | 390 |