The following data is part of a premarket notification filed by Guilin Fiteeth Medical Instrument Co., Ltd. with the FDA for Im/st Fixture System.
| Device ID | K212702 |
| 510k Number | K212702 |
| Device Name: | IM/ST Fixture System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Guilin FiTeeth Medical Instrument Co., Ltd. Southeast Side Of Renmin Road Extension Line, Yangtang Industrial Park, Lingui District Guilin, CN 541199 |
| Contact | Jun Zhou |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-26 |
| Decision Date | 2022-10-13 |