Search Results

The IM/ST Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The proposed device, IM/ST Fixture System, is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Implant system contain dental implant and abutment. The dental implant system, IM Implant System and ST Implant System, both of which are divided into mini implant and regular implant. IM Implant and ST Implant have different designs for the external thread section. The external thread part of IM implant is composed of conical shape, double thread and spiral groove, while The external thread part of ST implant is composed of conical shape, single thread, neck micro thread and cutting groove. Both IM implant and ST implant are available in diameters of 3.75, 4.2, 4.6 and 5.05mm and lengths of 7, 8.5, 10, 11.5, 13 and 15mm, and both are bone level. The "mini" and "regular" differ in size, but abutments are cross-compatible with both IM and ST implant types, and the abutment is attached to the implant by abutment screw and fastened to the implant. The material of abutment screw is Titanium Alloy (Ti-6A1-4V, ASTM F136).

The implants are bone level. The implants were made of Pure Titanium Grade 4 and underwent sandblasting and acid etching process. Modified surface testing (SEM/EDS) for blasted/etched surfaces was conducted to demonstrate removal of particles and chemicals from implant surface.

Abutment can be divided into healing abutment, straight abutment, multi-abutment, multi-angled abutment and temporary abutment. And it is divided into mini abutment and regular abutment. In addition, abutment also has three types of cylinder, angled cylinder and temporary cylinder.

The provided document is a 510(k) summary for the Guilin FiTeeth Medical Instrument Co., Ltd. IM/ST Fixture System. It describes the device and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and proving performance against them through a clinical study with detailed metrics like sensitivity, specificity, or AUC.

Therefore, the requested information for acceptance criteria and study details cannot be extracted as the document pertains to a medical device submission for substantial equivalence based on non-clinical tests and technological characteristics comparison, not an AI/Software as a Medical Device (SaMD) performance study with specific acceptance criteria, test sets, ground truth establishment, or human-in-the-loop effect sizes.

The document states:

• "No clinical study is included in this submission." on page 6.

Instead, the submission relies on:

• Non-clinical testing: This included biocompatibility (ISO 10993-1, USP ), dynamic fatigue (ISO 14801), material specifications (ASTM F136, ASTM F67), sterilization validation (ISO 17665-1, ISO 17665-2, ISO 11137-2, ISO 11137-1), accelerated aging (ASTM F1980), and MRI safety review. These tests verify that the device meets design specifications and complies with relevant standards.
• Technological characteristics comparison: The proposed device was compared in detail to a primary predicate device (K121995, OSSTEM IMPLANT CO.,LTD TS FIXTURE SYSTEM) and several reference devices for its abutment components. Differences in structure, body diameter, implant length, shelf life, and dimensions of various abutment types were assessed, and the manufacturer argued these differences do not affect substantial equivalence based on mechanical testing, coverage by predicate/reference ranges, or biocompatibility evaluations.

Since this is a submission for a traditional medical device (dental implant system) and not an AI/SaMD, the typical acceptance criteria and study details related to AI performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, independent test sets, expert ground truth adjudication) are not applicable or provided in this document.

Ask a specific question about this device