Search Results

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The High Retention Attachment System is compatible with the following implants: (list of compatible implants and diameters provided in the document).

The High Retention Attachment System is a system that provides rigid connection of fixed, partial, and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated. The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant. The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.

This document describes a 510(k) premarket notification for a dental device, the "High Retention Attachment System." It does not contain information about an AI/ML-driven medical device, hence no study details are provided to address the acceptance criteria for such a device. The content is primarily focused on demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, rather than performance testing against specific acceptance criteria for an AI algorithm.

Therefore, I cannot provide the requested information from the provided text as it does not pertain to the performance and validation of an AI/ML medical device.

Ask a specific question about this device

The LOCATOR® Overdenture Implant System is designed to retain overdentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.

The LOCATOR Overdenture Implant (LODI) was originally cleared under K120198. This submission is to add additional implant sizes to the LODI family that for distinction purposes, will hereinafter be called the Standard Ridge LOCATOR Overdenture Implant (LODI) System. The added implant sizes are listed in Table 1.0 below:

Table 1.0 Subiect Device Sizes

Identical to K120198, the subject LODI Standard Ridge System is designed to retain overdentures of partial dentures in the mandible or maxilla. The System includes a threaded and tapered endosseous dental implant that is made from the identical material, 6Al-4V ELI Titanium, and maintains its conformance to ASTM F136. The implant surface is roughened by Resorbable Blast Media (RBM) up to the abutment seating platform by the same manufacturing processes with the same manufacturing equipment as the existing LODI implant.

The provided text describes a 510(k) premarket notification for the "LOCATOR® Overdenture Implant System," specifically to add additional implant sizes to the existing system. The document focuses on demonstrating substantial equivalence to a predicate device (K120198) and a reference device (K192221) rather than presenting a study to prove acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

Therefore, many of the requested fields are not directly applicable to this type of submission which primarily relies on engineering and material testing to confirm equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This submission relies on engineering design principles, material science, and performance testing for mechanical, biological (biocompatibility, sterilization, cleanability, endotoxin), and shelf-life attributes, rather than a "test set" of clinical data. The acceptance criteria for manufacturing processes (e.g., sterilization, cleanability) are evaluated on representative devices or materials.
• Data Provenance: Not applicable in the context of clinical test data. The data provenance relates to internal manufacturing and testing records (e.g., ISO and USP standards for testing methods).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a clinical study involving expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a medical device (dental implant) and not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device (dental implant) and not an AI-driven algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the sense of clinical ground truth for a diagnostic device. The "ground truth" for this submission are the established engineering standards (e.g., ASTM F136 for material, ISO 11137-2 for sterilization, ISO 10993-1 for biocompatibility, USP for endotoxin) and the performance characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study/Approach:

The submission K203701 for the LOCATOR® Overdenture Implant System demonstrates substantial equivalence by showing that the new implant sizes are

• Made from the identical material (6Al-4V ELI Titanium conforming to ASTM F136).
• Have the same surface roughening process (Resorbable Blast Media, RBM).
• Maintain the same manufacturing processes and equipment.
• The Indications for Use remain within the scope of the predicate device (K120198).
• Performance testing (mechanical properties, corrosion, biocompatibility, sterilization, cleanability, fatigue, shelf-life, surface treatment, endotoxin) confirmed that adding new implant sizes either did not alter the existing safety and performance profile of the predicate device or, in cases of slight design changes (e.g., dual lead thread, blunted tip), did not create a new worst-case scenario. For instance, the larger cross-sectional area of the new implants was deemed to not introduce a new worst case for fatigue strength, and previous fatigue testing from K120198 was considered applicable. Similarly, the "new worst-case implant" (Standard Ridge LODI 4.9mm) was specifically tested for cleanability to meet acceptance criteria.

Note: "No clinical studies are provided as part of this 510(k) submission" is explicitly stated, reinforcing that this clearance relies on non-clinical (bench and material) testing and established equivalency principles.

Ask a specific question about this device