(163 days)
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
| Acceptance Criteria Category | Acceptance Criteria (from "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments") | Reported Device Performance (Dentis Dental Implant System) |
|---|---|---|
| Fatigue Testing | In accordance with ISO 14801:2007 under the worst-case scenario. | Performed in accordance with ISO 14801:2007 under the worst-case scenario. |
| Sterilization Validation | In accordance with ISO 11137-1:2006, ISO 11137-2:2006. | Performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006. |
| Biocompatibility Evaluation | Not explicitly stated, but generally involves comparison with established biocompatible materials. | Biocompatibility evaluation performed by comparing materials and manufacturing process with the predicate device. |
| Surface Treatment Analysis | Not explicitly stated, but generally involves characterization of the treated surface. | Surface treatment analysis was used to support the decision of substantial equivalence. |
| Material Composition | The predicate device materials (Commercially pure titanium GR.3 and GR.4 (ASTM-F-67), Ti-6Al-4V ELI, Gold Alloy, Acetal) serve as a benchmark. | Subject device materials are Commercially pure titanium GR.4 (ASTM-F-67) for dental implants and Titanium alloy (Ti-6Al-4V ELI) for abutments, matching or being similar to the predicate. Other materials like PEEK, Co-Cr-Mo alloy are also listed for specific components. |
| Intended Use | The predicate device's intended use serves as a benchmark for substantial equivalence. | Identical to predicate devices (for use in edentulous sites in the mandible or maxilla for support for various prosthetic restorations). |
| Design | Similar to predicate device (Morse Taper with Tread). | Morse Taper with Tread. |
| Fixture Diameter & Length | Predicate: Diameter 3.5, 3.7, 4.1, 4.3, 4.8, 5.5, 6.0mm; Length 7-14mm. | Subject: Diameter 3.7, 4.1, 4.3, 4.8mm; Length 7-14mm (with addition of 7mm and 14mm fixtures and various abutments). |
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.
§ 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.