(67 days)
The SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
The SM Implant System is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5, and 5.3 mm, and lengths from 8mm to 14 mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.
The provided text describes a 510(k) premarket notification for the "SM Implant Systems" (K061797), an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics typically found in efficacy studies for novel devices.
Therefore, the input document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9. The document explicitly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" (Section 13-8. Performance), but it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for device performance.
The 510(k) summary (and the FDA's response letter) confirms that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and a study proving those criteria were met.
Summary of what is possible to extract from the provided text:
- Device Name: SM Implant Systems
- Classification Name: Endosseous Dental Implant System
- Predicate Device: ANKYLOS® DENTAL IMPLANT SYSTEM (K012087)
- Performance information: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No details provided)
- Type of Study (implied by 510(k)): Substantial equivalence determination based on comparison to a predicate device, supported by laboratory testing for functionality and conformance to design requirements. This is not a clinical efficacy study with acceptance criteria as requested in the prompt.
§ 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.