The following data is part of a premarket notification filed by Taiwan Implant Technology Company, Ltd. with the FDA for Maxfit Ii Dental Implant System.
| Device ID | K151588 |
| 510k Number | K151588 |
| Device Name: | MaxFit II Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch 5F., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung, TW 82151 |
| Contact | Ching-chieh Huang |
| Correspondent | Ching-chieh Huang Taiwan Implant Technology Company, Ltd. Kaohsiung Science Park Branch 5F., No.63, Luke 2nd Rd., Luzhu Dist Kaohsiung, TW 82151 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2016-04-25 |
| Summary: | summary |