(469 days)
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).
HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.
HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.
CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).
lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).
The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).
The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.
The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.
If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.
§ 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.