The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Hysil Plus Impression Materials.
| Device ID | K210041 |
| 510k Number | K210041 |
| Device Name: | HySil Plus Impression Materials |
| Classification | Material, Impression |
| Applicant | Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, KR 48002 |
| Contact | Jinwoo Bae |
| 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 | 2021-01-07 |
| Decision Date | 2021-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800121709309 | K210041 | 000 |
| 08809917144621 | K210041 | 000 |
| 08809917144614 | K210041 | 000 |
| 08809917144607 | K210041 | 000 |
| 08809917144591 | K210041 | 000 |
| 08809917144584 | K210041 | 000 |
| 08809917144577 | K210041 | 000 |
| 08809917144560 | K210041 | 000 |
| 08809917144553 | K210041 | 000 |
| 08809917144638 | K210041 | 000 |
| 08800121709217 | K210041 | 000 |
| 08800121709293 | K210041 | 000 |
| 08800121709286 | K210041 | 000 |
| 08800121709279 | K210041 | 000 |
| 08800121709262 | K210041 | 000 |
| 08800121709255 | K210041 | 000 |
| 08800121709248 | K210041 | 000 |
| 08800121709231 | K210041 | 000 |
| 08800121709224 | K210041 | 000 |
| 08800121773621 | K210041 | 000 |