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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.

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