Transparent A-silicone with high final hardness and short setting time for temporary restaurations, bite-registration in difficult cases and x-ray splints. 2 x 50 ml double cartridges incl.…
Transparent A-silicone with high final hardness and short setting time for temporary restaurations, bite-registration in difficult cases and x-ray splints. 2 x 50 ml double cartridges incl. 12 mixing tips, green.
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Regofix transparent | Listed by | Dreve Dentamid Gmbh, Germany |
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2017-01-24 |
| Record revised | 2022-12-05 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 18 to 28 °C |
| Distribution end date | 2018-05-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.