The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Orthodontic Mini Screw Extended System.
| Device ID | K202790 |
| 510k Number | K202790 |
| Device Name: | Syntec Orthodontic Mini Screw Extended System |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Syntec Scientific Corporation No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang Chang Hua, TW 50971 |
| Contact | Nicole Tseng |
| Correspondent | Nicole Tseng Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, TW 10652 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2021-09-17 |