Duns Number:316699578
Device Description: This die silicone is an addition-curing silicone for the extraoral fabrication of dental m This die silicone is an addition-curing silicone for the extraoral fabrication of dental models.Indirect composite restorations can be fabricated chairside on this silicone model.The die silicone’s special curing formula allows you ample time to apply the material.The material is fully cured after 4 minutes, at which time you can then start modelling therestorations.
Catalog Number
1186
Brand Name
die silicone
Version/Model Number
1186
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
da306840-6e84-4e2f-b301-1eabc15c1927
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |