The following data is part of a premarket notification filed by Syntec Scientific Corporation - Taipei Office with the FDA for Syntec Wetali Orthodontic Mini Screws.
| Device ID | K142001 |
| 510k Number | K142001 |
| Device Name: | SYNTEC WETALI ORTHODONTIC MINI SCREWS |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE 3F., NO. 96, SEC. 3, ZHONGXIO EAST ROAD DA'AN DIST., Taipei, TW 10652 |
| Contact | Kavin Chu |
| Correspondent | Kavin Chu 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2015-03-18 |
| Summary: | summary |