The following data is part of a premarket notification filed by Bomei Co, Ltd. with the FDA for Obs Anchorage Screw, Biokey Anchorage Screw.
| Device ID | K202278 |
| 510k Number | K202278 |
| Device Name: | OBS Anchorage Screw, Biokey Anchorage Screw |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Bomei Co, Ltd. 4F., No.1492-2, Chunrih Rd., Taoyuan Dist. Taoyuan City, TW 33051 |
| Contact | Steven Pan |
| Correspondent | Chih-hao Kao Voler Biotech Consulting Co. Ltd. No.3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City, TW 10480 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2021-01-08 |