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 |