The following data is part of a premarket notification filed by Biotem Co., Ltd. with the FDA for Ir Type Implant System.
| Device ID | K171185 |
| 510k Number | K171185 |
| Device Name: | IR Type Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Biotem Co., Ltd. 57, Sasang-ro , 401 Beon-gil Sasang-gu Busan, KR |
| Contact | Hong Koo Yeo |
| Correspondent | Joyce Bang Provision Consulting Group Inc. 14071 Peyton Dr. #967 Chino Hills, CA 91709 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-12-01 |
| Summary: | summary |