Duns Number:316133664
Device Description: Hardening paste (catalyst) for mixing with condensation-curing impression silicones (C-sil Hardening paste (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.
Catalog Number
00950
Brand Name
BISICO Paste Hardener
Version/Model Number
00950
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"
Yes
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
e94207a8-5744-4f3c-9635-2cbed2b6b0dd
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 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 |