The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for K3.
| Device ID | K183347 |
| 510k Number | K183347 |
| 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 08504 |
| Contact | Hyeri Han |
| Correspondent | Peter Lee Hiossen Inc. 85 Ben Fairless Dr Pennsylvania, 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 | 2018-12-03 |
| Decision Date | 2019-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000995052 | K183347 | 000 |
| 08800000995045 | K183347 | 000 |