(99 days)
The Rescue External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
The Rescue External Implant System consists of machined titanium, screw-form, rootform endosseous dental implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
This 510(k) summary for the Kosi302 Rescue External Implant System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" to previously cleared devices. This regulatory pathway typically relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices, rather than presenting new performance study data with defined acceptance criteria.
Here's why the requested information is absent:
- No Performance Standards Established by FDA: The document explicitly states in section 8, "Performance Standards: FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Implant System meet applicable standards." This indicates that the FDA did not require specific performance metrics or studies to be submitted for this device class at the time.
- Substantial Equivalence: The core of this 510(k) is to show that the "Rescue External Implant System is essentially an addition to the predicate device previously cleared for marketing by FDA... The noted difference in the design and material does not effectively change the performance of the device and Rescue External Implant System is substantially equivalent to predicate devices." This means the manufacturer is arguing that because the new device is very similar to an already-approved device, it does not need to re-demonstrate safety and effectiveness through new performance studies.
- Focus on Design and Material Comparison: The description outlines the device's components (machined titanium, screw-form, root-form endosseous dental implants) and its intended use, emphasizing its similarity to existing cleared devices rather than providing novel performance data.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria or a supporting study based on the provided text. The document's purpose is to establish substantial equivalence, not to present new performance study results.
§ 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.