(144 days)
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:
- Indications for Use: The Magicore System is intended to replace missing teeth to restore chewing function, similar to the predicate devices.
- Materials: All devices are made of Titanium Alloy Ti-6Al-4V Eli (ASTM F136).
- 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.
- 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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.