The following data is part of a premarket notification filed by T-plus Implant Tech. Co., Ltd. with the FDA for A Plus Internal Fixture System.
| Device ID | K152786 |
| 510k Number | K152786 |
| Device Name: | A Plus Internal Fixture System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | T-PLUS IMPLANT TECH. CO., LTD. NO.41, WUQUAN 6TH RD., WUGU DIST., New Taipei City, TW 24889 |
| Contact | Dana Cheng |
| Correspondent | Dana Cheng T-PLUS IMPLANT TECH. CO., LTD. NO.41, WUQUAN 6TH RD., WUGU DIST., New Taipei City, TW 24889 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-06-07 |
| Summary: | summary |