The following data is part of a premarket notification filed by Osstem Implant Co.,ltd. with the FDA for K3.
| Device ID | K152830 |
| 510k Number | K152830 |
| Device Name: | K3 |
| Classification | Unit, Operative Dental |
| Applicant | OSSTEM IMPLANT CO.,LTD. 1ST FLOOR, B-DONG, 135 GASAN DIGITAL 2-RO, GEUMCHEON-GU Seoul, KR 153-759 |
| Contact | Byeunghun Kim |
| Correspondent | David Kim HIOSSEN INC. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2017-04-20 |
| Summary: | summary |