The following data is part of a premarket notification filed by T-plus Implant Tech. Co., Ltd. with the FDA for St Internal Implant System.
| Device ID | K190919 |
| 510k Number | K190919 |
| Device Name: | ST Internal Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | T-Plus Implant Tech. Co., Ltd. No.41, Wuquan 6th Rd., Wugu Dist. New Taipei County, TW 24889 |
| Contact | Dana Cheng |
| Correspondent | Yuhua Chen PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei County, TW 23553 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-09 |
| Decision Date | 2020-02-27 |