Search Results

The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli(Conforming to ASTM Standard F-136). The Magicore System is consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media). The Fixture diameters are 4, 4.5, 5, 5, 6, 6.5mm and lengths are 7, 9, 11, 13mm in this system. The contained various abutments and accessories in the system are abutment screw, magicore abutment &cap, healing cap (color anodizing: yellow, blue, green, and purple). The abutments are provided straight only and that they are no intended to be modified to provide an angle correction. Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

The provided document is a 510(k) premarket notification for a dental implant system (Magicore System). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for acceptance criteria and device performance as would be required for novel or higher-risk devices.

Therefore, the document does not contain the detailed information requested about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Instead, the submission focuses on comparing the Magicore System to predicate devices to demonstrate substantial equivalence based on:

1. Indications for Use: The Magicore System is intended to replace missing teeth to restore chewing function, similar to the predicate devices.
2. Materials: All devices are made of Titanium Alloy Ti-6Al-4V Eli (ASTM F136).
3. General Shape Design, Surface, Connection Method, Application Method, and Sterilization Method: These are stated to be similar between the subject device and the predicate devices.
4. Non-clinical Data: This includes sterilization validation (ISO 11137-1:2006, ISO 11137-2:2006), surface treatment analysis, biocompatibility evaluation (relying on predicate materials or FDA consensus standards), and shelf-life validation (ASTM 1980).

The document states: "Any differences between the Mazicore System and predicate device do not raise new types of safety or effectiveness issues. Accordingly we can claim the substantially equivalence of the Magicore System to predicate device."

In summary, none of the requested information regarding acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device), sample sizes for clinical test sets, expert ground truth, adjudication, or MRMC studies are present in this 510(k) submission. This is standard for 510(k) applications for dental implants, which typically rely on non-clinical data and comparison to predicates for demonstration of substantial equivalence.

Ask a specific question about this device