(224 days)
Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.
The Intra-Lock Mini Drive-Lock™ Dental Implant System consists of machined Titanium, screw-form dental implants, 2.0mm and 2.5mm in diameter and available in lengths of 10mm, 11.5mm, 13mm, 15mm and 18mm. The implant raw material consists of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401). The implants are sterile packaged.
The provided text describes a 510(k) summary for the "Mini Drive-Lock™ Dental Implant System." This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria from a specific clinical study with performance metrics.
Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document is primarily a regulatory submission outlining the device's description, intended use, and comparison to existing legally marketed devices.
Specifically, the document states: "This submission is a Traditional 510(k) as described in Safety and Performance: FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled Endosseous Implants 872-3640."
This indicates that the submission relies on demonstrating substantial equivalence, not necessarily on a new clinical study with specific acceptance criteria and performance outcomes.
Without a clinical study report or a different type of performance testing document, the information requested in points 1-9 cannot be provided.
§ 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.