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The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.

The provided text describes the regulatory clearance of a dental implant system and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or technical study setup.

The submission is an "Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA guidance documents and substantial equivalence to predicate devices rather than presenting new performance data from a dedicated study.

Therefore, I cannot fulfill the request for information regarding:

• A table of acceptance criteria and reported device performance: This type of data is not present in the provided document.
• Sample size used for the test set and data provenance: No test set is described.
• Number of experts used to establish ground truth and qualifications: No ground truth establishment process is described.
• Adjudication method: Not applicable as no test set or ground truth establishment is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical dental device, not an algorithm.
• Type of ground truth used: Not applicable as no ground truth is established.
• Sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
• How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory process for enabling the marketing of the device based on its substantial equivalence to previously approved devices and adherence to relevant guidance documents.

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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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