The following data is part of a premarket notification filed by Ze Fang Technology Co., Ltd. with the FDA for Mico One Orthodontic Screw.
| Device ID | K202163 |
| 510k Number | K202163 |
| Device Name: | Mico One Orthodontic Screw |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Ze Fang Technology Co., Ltd. No.17, Aly. 81, Ln. 2, Sec. 1, Zhongxing Rd., Dali Dist., Taichung City, Taiwan Taichung, TW 412 |
| Contact | Anita Chen |
| Correspondent | Anita Chen ZhengCheng Consulting Limited Company No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City, TW 238 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2022-10-07 |