The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec Dental Implant.
| Device ID | K111189 |
| 510k Number | K111189 |
| Device Name: | SYNTEC DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei City, TW 106 |
| Contact | Chia-ching Lee |
| Correspondent | Chia-ching Lee SYNTEC SCIENTIFIC CORP. 3F1. 96 CHUNG HSIAO E. RD. SEC. 3 Taipei City, TW 106 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-28 |
| Decision Date | 2012-12-20 |
| Summary: | summary |