The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Hysil Super Fast Impression Materials.
| Device ID | K192941 |
| 510k Number | K192941 |
| Device Name: | HySil Super Fast Impression Materials |
| Classification | Material, Impression |
| Applicant | Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 48002 |
| Contact | Jungmin Yoo |
| Correspondent | Peter Lee 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 | 2019-10-18 |
| Decision Date | 2020-01-30 |
| Summary: | summary |