The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Mazic Duro.
| Device ID | K163346 |
| 510k Number | K163346 |
| Device Name: | MAZIC Duro |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VERICOM CO., LTD. 48 Toegyegongdan 1-gil Chuncheon-si, KR 200-944 |
| Contact | Myung-hwan Oh |
| Correspondent | Myung-hwan Oh VERICOM CO., LTD. 48 Toegyegongdan 1-gil Chuncheon-si, KR 200-944 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-29 |
| Decision Date | 2017-03-17 |
| Summary: | summary |