The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec Orthodontic Mini Screw.
| Device ID | K090476 |
| 510k Number | K090476 |
| Device Name: | SYNTEC ORTHODONTIC MINI SCREW |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei, TW 106 |
| Contact | Susan Cheng |
| Correspondent | Susan Cheng SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei, TW 106 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-06-18 |
| Summary: | summary |