The following data is part of a premarket notification filed by Osstem Implant Co., Ltd with the FDA for Hyflex Heavy, Hyflex Mono, Hyflex Light.
| Device ID | K151262 |
| 510k Number | K151262 |
| Device Name: | Hyflex Heavy, Hyflex Mono, Hyflex Light |
| Classification | Material, Impression |
| Applicant | Osstem Implant Co., Ltd 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 612-070 |
| Contact | Heekwon Son |
| Correspondent | Patrick Lim HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2015-09-21 |
| Summary: | summary |