The following data is part of a premarket notification filed by Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.s. with the FDA for R&d Series Nova Compo N.
| Device ID | K192178 |
| 510k Number | K192178 |
| Device Name: | R&D Series Nova Compo N |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Fetih Mahallesi Mahir Sokak No:5/201 Konya, TR 42030 |
| Contact | Husamettin Sonmez |
| Correspondent | Husamettin Sonmez Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Fetih Mahallesi Mahir Sokak No:5/201 Konya, TR 42030 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2019-12-20 |