The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Dentium Implantium & Superline Prosthetics.
| Device ID | K172640 |
| 510k Number | K172640 |
| Device Name: | Dentium Implantium & SuperLine Prosthetics |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 16985 |
| Contact | Sangpil Yoon |
| Correspondent | Sangpil Yoon Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 16985 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-05-14 |