The following data is part of a premarket notification filed by Osstem Implant Co Ltd with the FDA for Hysil Impression Materials.
| Device ID | K181236 |
| 510k Number | K181236 |
| Device Name: | HySil Impression Materials |
| Classification | Material, Impression |
| Applicant | OSSTEM IMPLANT CO LTD 203, GEOJE-DAERO YEONJE-GU Busan, KR 611-804 |
| Contact | Jungmin Yoo |
| Correspondent | David Kim 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 | 2018-05-10 |
| Decision Date | 2018-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800121720014 | K181236 | 000 |
| 08800121720007 | K181236 | 000 |