(181 days)
The Hero II Dental Implant System and the IS Dental Implant System are 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 terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The Hero II Dental Implant system and the IS Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).
The provided document does not contain acceptance criteria or study data for device performance in a clinical context.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence of the Hero II Dental Implant System and the IS Dental Implant System to a predicate device (GS FIXTURE SYSTEM by OSSTEM IMPLANT CO., LTD (K072896)). Substantial equivalence is primarily proven through similarities in:
- Intended Use: Both the subject and predicate devices are dental implant systems used in the jaw for missing teeth, supporting various types of restorations, and for single or two-stage surgical procedures with delayed loading.
- Technological Characteristics: Both are threaded, root form implants made of titanium with RBM roughened surfaces and share the same internal hexagon abutment connection system. They are also bone-level implants with similar body shapes.
- Materials and Surface Treatment: Made of commercially pure titanium with RBM surface treatment.
- Sizes: Similar size ranges for fixtures and abutments.
- Sterilization Method: Gamma irradiation for fixtures.
Non-Clinical Testing:
The document mentions non-clinical testing performed to support safety and shelf life, which includes:
- Sterilization Validation: In accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Shelf Life Validation: Three-year shelf life validated through accelerating testing.
- Chemical and SEM image analyses: To verify no residual after RBM treatment on the fixtures.
Therefore, I cannot provide the requested information in the table format or answer the questions related to clinical study design, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided 510(k) summary. The 510(k) process for substantial equivalence typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if sufficient evidence of technological similarity and non-clinical performance (like material properties, biomechanical characteristics, sterilization) exists.
§ 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.