Duns Number:315471722
Device Description: Capsule Extruder 2 is the device designed for extrusion and direct application ofChemFil® Capsule Extruder 2 is the device designed for extrusion and direct application ofChemFil® Rock restorative capsules
Catalog Number
60606596
Brand Name
Capsule Extruder 2
Version/Model Number
60606596
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
KXR
Product Code Name
APPLICATOR, RESIN
Public Device Record Key
26f8325f-cd75-4a8a-96cb-fe2413accab8
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
December 16, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |