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510(k) Data Aggregation
(220 days)
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.
The CreoDent Solidex® Customized Abutment is a dental device intended to support prosthetic devices with endosseous implants in partially or completely edentulous patients. The study aimed to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical testing.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The information provided does not explicitly state numerical "acceptance criteria" for performance metrics in a pass/fail format typical of many medical device studies. Instead, substantial equivalence is established by demonstrating that the device has the same intended use, fundamental scientific technology, and comparable technological characteristics and performance to predicate devices, with any differences being "mitigated" or demonstrated to be safe and effective.
The provided document details comparisons between the CreoDent Solidex® Customized Abutment and several predicate devices across various technological characteristics. The "reported device performance" is primarily qualitative, asserting mechanical strength and compatibility, and is supported by specific non-clinical tests.
| Feature / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Material | Same as or comparable to predicate device materials (Ti-6Al-4V Eli titanium alloy, ASTM F-136 standard). | Abutment and Screw are Ti-6Al-4V Eli titanium alloy, meeting ASTM F-136 standard. (Same or higher grade than predicates). |
| Performance | Allows prosthesis to be cemented or screw-retained; abutment screw secures abutment to implant; sufficient mechanical strength. | Allows prosthesis to be cemented or screw-retained; abutment screw secures abutment to implant. Static/Fatigue testing per ISO 14801:2007E confirmed sufficient mechanical strength for intended clinical application. |
| Indications for Use | Same intended use as predicate devices (support prosthetic device with endosseous implant in partially/completely edentulous patients, single or multiple restorations). | Identical indications for use as primary predicate, and comparable to reference predicates. Compatibility with specific implant systems demonstrated. |
| Dimensions & Angulations | Comparable dimensions and angulations to predicate devices, with any differences not compromising safety/effectiveness. Max angulation up to 20 degrees from implant axis. | Customization limited by minimum dimensions (wall thickness, diameter, post height, collar height, angulation). Max angulation 20 degrees. Differences in angulation compared to some predicates (e.g., 30 degrees) were mitigated by testing. |
| Connection & Compatibility | Compatible with specific listed endosseous implant systems. | Compatibility explicitly stated and demonstrated with listed implant systems (Camlog, Thommen SPI Element, Dentium Implantium, Lifecore PrimaConnex). Reverse engineering dimensional analysis confirmed compatibility with OEM implant bodies. |
| Sterilization | Sterilized according to established standards. | Sterilization performed according to ISO 17665-1. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing rather than a clinical study with a "test set" of patient data.
- Sample Size for Non-clinical Testing: The document does not specify the exact number of physical samples (e.g., abutments, screws, implants) used for static/fatigue testing or reverse engineering dimensional analysis. It refers to "worst-case scenario" testing for the abutment connection platform.
- Data Provenance: The data is from non-clinical bench testing rather than human patient data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's clearance is based on non-clinical testing and demonstration of substantial equivalence, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to mechanical performance standards and dimensional compatibility, verified by engineering and material science evaluations.
4. Adjudication Method for the Test Set
Not applicable, as there is no test set in the context of clinical images or data requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this dental abutment device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical dental device (abutment) and not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Mechanical Standards: Adherence to established international standards for dental implants and abutments (e.g., ISO 14801:2007E for dynamic fatigue).
- Material Specifications: Compliance with material standards (ASTM F-136 for Ti-6Al-4V Eli titanium alloy).
- Dimensional Compatibility: Verification through reverse engineering dimensional analysis against original equipment manufacturer (OEM) compatible implant bodies, abutments, and fixation screws.
- Sterilization Standards: Compliance with ISO 17665-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical dental device; there is no "training set" in the machine learning sense. The design and manufacturing processes are likely informed by extensive engineering knowledge and design principles accumulated over time for similar devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/algorithm. For a physical device, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to accepted industry standards and regulatory requirements.
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