The following data is part of a premarket notification filed by Imicryl Dis Malzemeleri San. Ve Tic. A.s. with the FDA for Imicryl Impression Materials.
| Device ID | K213890 |
| 510k Number | K213890 |
| Device Name: | IMICRYL Impression Materials |
| Classification | Material, Impression |
| Applicant | IMICRYL Dis Malzemeleri San. Ve Tic. A.S. Fetih Mahallesi Mahir Sokak No:5/201 Konya, TR 42030 |
| Contact | Husamettin Sonmez |
| Correspondent | Husamettin Sonmez IMICRYL Dis Malzemeleri San. Ve Tic. A.S. Fetih Mahallesi Mahir Sokak No:5/201 Konya, TR 42030 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-02-11 |