Search Results

The Dentis Dental Implant System is an endosseous dental implant that 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 when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:

1. i-Clean System: Fixture (i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture), Abutment (i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment)
2. s-Clean System: Fixture (s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture), Abutment (s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment)
3. e-Clean System: Fixture (e-Clean Tapered Fixture/ e-Clean Tapered II Fixture), Abutment (e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment)
   The surface of the fixture has been treated with RBM (Resorbable Blasted media).

This document discusses the Dentis Dental Implant System and its substantial equivalence to previously cleared predicate devices. Since this is an unassisted device (a dental implant system), the concepts of "acceptance criteria for device performance," "test set," "training set," "experts for ground truth," "adjudication method," and "MRMC study" are not directly applicable in the way they would be for an AI/ML-driven device.

Instead, the "acceptance criteria" here relate to demonstrating that the new device (Dentis Dental Implant System with added fixtures and abutments) is as safe and effective as existing legally marketed devices. This is typically achieved through comparison to predicate devices and non-clinical testing.

Here's an interpretation of the requested information in the context of this unassisted medical device:

1. Table of Acceptance Criteria and the Reported Device Performance

For an unassisted device like this, "acceptance criteria" are not performance metrics in the sense of accuracy, sensitivity, or specificity. Instead, they are the criteria used to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. These typically involve demonstrating equivalence in:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: How the device achieves its intended purpose (e.g., design, materials, surface treatment, sterilization, packaging, shelf life).
• Performance Data: Non-clinical tests to confirm the device meets safety and functional requirements.

The reported device "performance" is therefore its adherence to these characteristics, demonstrating it is as safe and effective as the predicate.

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

• Sample Size: Not applicable in the context of an AI/ML device. For this unassisted medical device, "testing" refers to non-clinical bench testing (e.g., LAL, sterilization validation, shelf-life validation, biocompatibility) rather than a dataset for evaluating an algorithm's performance. The document doesn't specify the number of units or samples used for these non-clinical tests.
• Data Provenance: The non-clinical tests were performed by Dentis Co., Ltd. (South Korea) or leveraged from prior submissions for their predicate devices. The tests adhere to international standards (e.g., ISO, ASTM, USP). The country of origin for the device is South Korea.

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

• This concept is not applicable for this type of unassisted medical device. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices where human experts define the correct diagnosis or outcome. For a dental implant system, the "ground truth" is typically defined by engineering specifications, material standards, and biological compatibility standards, evaluated through physical and chemical testing.

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

• This concept is not applicable as there is no test set in the AI/ML sense, and no human interpretation requiring adjudication.

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

• No MRMC study was done. This device is an implant system, not an AI-assisted diagnostic or interpretative tool that would involve human "readers."

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

• This is not applicable as this is not an algorithm or AI device.

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

• For this device, the "ground truth" is defined by established engineering and material standards, biological compatibility requirements (ISO 10993 series), and manufacturing process controls. The tests (e.g., LAL, sterilization, shelf life, biocompatibility) confirm that the device meets these pre-defined standards. There is no "ground truth" derived from expert consensus on medical images or patient outcomes data in the way an AI/ML device would use it.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth established for it.

Ask a specific question about this device

The Dentis Dental 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.

An endosseous dental implant is a device made of Pure Titanium Grade 4. Dentis Dental Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. Dentis Dental Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The surface of the system has been treated with RBM (Resorbable Blasted media). The fixture diameters are 3.7, 4.1, 4.3, 4.8mm and lengths are 7, 8, 10, 12, 14 mm in this system. The contained various abutments in the system are click bridge, cover screw, gold cylinder, solid abutment, couple abutment, angled abutment, healing cap, abutment screw, retaining screw, temporary cylinder, CCM cylinder, and connector. The rage of the abutment diameters is 1.96 mm to 7.4mm and range of abutment lengths is 3.7mm to 14.25mm. The Connector, MU (Solid, couple, angled, abutment screw), MU Healing cap, and MU Retaining Screw are made of Ti-6Al-4V ELI. The MU click bridge body and MU Temporary Cylinder are made of Titanium Grade 4. The MU Click Bridge Cap is made of PEEK. The MU Gold Cylinder (Body) is made of Gold Alloy. The MU Gold Cylinder (Plastic Sleeve) and MU CCM Cylinder (Plastic Sleeve) are made of Acetal. The MU CCM Cylinder (Body) is made of Co-Cr-Mo alloy. The possible angulation range of angled abutments is 17 to 30 degrees. The Fixtures are supplied sterile and the abutments are provided non-sterile. The abutments should be sterilized before use.

The provided text (K150344) describes the Dentis Dental Implant System. Here's an analysis of the acceptance criteria and supporting studies based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of clinical data or image-based AI evaluation (which usually refers to patient data) does not apply here. The "test set" for this device consists of physical implant components subjected to standardized engineering tests.

• Sample Size for Physical Testing: Not explicitly stated. For bench testing, sample sizes are typically determined by relevant ISO standards (e.g., ISO 14801 for fatigue testing, which specifies a minimum of 5 samples per test group). The document only states that testing was "performed in accordance with ISO 14801" and "ISO 11137-1, 11137-2."
• Data Provenance: The testing was non-clinical (bench testing), not derived from human or animal subjects. The data originated from the manufacturer's (Dentis Co., Ltd., based in South Korea) testing facilities or subcontracted laboratories specializing in medical device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the type of data presented. "Ground truth" usually refers to a definitive diagnosis or finding established by human experts or pathology in clinical studies. For bench testing of physical devices, the "ground truth" is defined by the objective pass/fail criteria of the engineering standards themselves (e.g., whether a device withstands a certain load for a specified number of cycles without fracture). There are no human experts establishing a "ground truth" for the performance of the implant in the clinical sense mentioned here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements between human readers/experts in clinical studies. For bench testing, the results are typically quantitative and objectively measured against pre-defined performance specifications of the standard.

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 device is a dental implant system (a physical medical device), not an Artificial Intelligence (AI) diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For this specific device, the "ground truth" for its performance is established by objective engineering specifications and standardized test methods. For example:

• Fatigue Testing: The "ground truth" is whether the implant system can withstand repetitive loading for a certain number of cycles without failure, as defined by ISO 14801:2007. The absence of fracture or significant deformation under specified conditions is the "truth."
• Sterilization Validation: The "ground truth" is that the sterilization process achieves a predefined Sterility Assurance Level (SAL), as defined by ISO 11137-1:2006 and ISO 11137-2:2006.
• Biocompatibility: The "ground truth" is that the materials used are non-toxic and do not elicit an adverse biological response, typically established by historical data on similar materials (predicate device) and compliance with relevant ISO 10993 standards (though not explicitly detailed beyond "comparing materials... with the predicate device").

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are used for machine learning models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it.

Ask a specific question about this device

The Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region.

The Dentis Dental Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text is a 510(k) summary for the Dentis Dental Implant System. It outlines the device information, indications for use, and a comparison to predicate devices, ultimately stating substantial equivalence. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, it is not possible to complete the requested table and study description based on the provided input.

The 510(k) summary focuses on demonstrating equivalence to previously cleared devices rather than providing detailed performance study data against specific acceptance criteria. This is typical for 510(k) submissions where clinical performance is often inferred from the predicate device through non-clinical testing (e.g., material properties, mechanical testing) and comparison of intended use.

To answer your questions, additional documentation beyond this 510(k) summary would be required, such as a detailed test report or clinical study report.

Ask a specific question about this device

The Dentis Dental Implant system is an endosseous dental implant that is indicated to use 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 Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine

The provided text describes the Dentis Dental Implant System and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about MRMC or standalone studies.

The "Performance" section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that performance testing was done, but the details of these tests, including the criteria and results, are not provided in this summary.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer the other specific questions about the study design, ground truth, or expert involvement based on the provided text alone. The document focuses on regulatory equivalence and device description rather than detailed clinical or performance study results.

Ask a specific question about this device