Duns Number:388000846
Device Description: Transparent A-silicone with high final hardness and short setting time for temporary resta Transparent A-silicone with high final hardness and short setting time for temporary restaurations, bite-registration in difficult cases and x-ray splints. 8 x 50 ml double cartridges
Catalog Number
D504877
Brand Name
Regofix transparent
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053427
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
5f28b466-da12-42de-82e3-3413c0455865
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
January 24, 2017
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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |