The following data is part of a premarket notification filed by Biomate Medical Devices Technology Co., Ltd. with the FDA for Biomate Dental Implant System.
| Device ID | K170732 |
| 510k Number | K170732 |
| Device Name: | Biomate Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Biomate Medical Devices Technology Co., Ltd. 1F., No.59, Luke 2nd Rd Luzhu Dist Kaohsiung City, TW 820 |
| Contact | Leslie Su |
| Correspondent | Leslie Su Biomate Medical Devices Technology Co., Ltd. 1F., No.59, Luke 2nd Rd Luzhu Dist Kaohsiung City, TW 820 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2018-10-26 |
| Summary: | summary |