(225 days)
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit 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 CreoDent Solidex® Customized Abutment is compatible with the following:
- Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm
- Hiossen TS Implants 3.5mm, 4.0mm
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 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. Solidex® Customized Abutments are compatible with:
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, height, collar height and angulation.
The medical device under consideration is the CreoDent Solidex® Customized Abutment. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a standalone clinical study. Therefore, some of the requested information, such as sample sizes for test/training sets, number/qualifications of experts for ground truthing, adjudication methods, and MRMC studies, is not typically part of a 510(k) submission for this type of device and is not present in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CreoDent Solidex® Customized Abutment are implicitly derived from its substantial equivalence to predicate devices in material, indications for use, performance characteristics, and dimensions/angulations, backed by non-clinical testing. The performance is assessed against the established standards and the characteristics of the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Derived from Predicate Equivalence) | Reported Device Performance (CreoDent Solidex® Customized Abutment) |
|---|---|---|
| Material | Abutment: Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | |
| Screw: CP TI Gr4 meets ASTM F67 Standard. (Comparable to predicate materials) | Abutment: Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | |
| Screw: CP TI Gr4 meets ASTM F67 Standard. (Reported as a higher grade material with more tensile strength than the predicate for the abutment, and comparable for the screw). | ||
| Performance Characteristics | Allows prosthesis to be cemented or screw-retained to the abutment, with the abutment screw securing it to the endosseous implant. (Comparable to predicate functionality). | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. |
| Indications for Use | Intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous, for single or multiple-unit restorations, cemented or screw-retained. Compatible with Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm and Hiossen TS Implants 3.5mm, 4.0mm. (Comparable to predicate except for specific compatible implant bodies). | Intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous, for single or multiple-unit restorations, either cemented or screw retained. Compatible with Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm and Hiossen TS Implants 3.5mm, 4.0mm. |
| Dimensions & Angulations | Personalized abutment design with minimum dimensions for wall thickness, diameter, height, collar height, and angulation. Angles not to exceed up to 20 degrees from the implant axis. (Compared to predicate's specific compatible implant sizes and angulation limits). | Customizable to patient requirements, limited by minimum dimensions. Abutment sizes for specified Astra Tech Osseospeed TX Implants (3.5mm, 4.5mm) and Hiossen TS Implants (3.5mm, 4.0mm). Angles not to exceed up to 20 degrees from the implant axis (for Astra Tech and Hiossen TS compatibility). This is a difference from one reference predicate which had 30 degrees angulation but is mitigated by testing. |
| Mechanical Strength & Compatibility | Sufficient mechanical strength for intended clinical application and compatibility with specified implant systems, as demonstrated by non-clinical testing (ISO 14801:2007E, reverse engineering, sterilization validation). This is the key performance "acceptance criteria" evaluated via testing. | Static/Fatigue testing in accordance with ISO 14801:2007E (worst-case scenario), reverse engineering dimensional analysis, and sterilization validation (ISO 17665-1) were performed. These results demonstrated that the Solidex® customized Abutment has sufficient mechanical strength and is compatible with the Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addresses the differences in compatible implant bodies and angulation limitations compared to predicates. |
Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is a non-clinical testing study focused on mechanical performance and compatibility.
- Study Type: Non-clinical testing, specifically static/fatigue testing, reverse engineering dimensional analysis, and sterilization validation.
- Standards Followed: ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) and ISO 17665-1 (Sterilization validation).
- Purpose: To demonstrate that the CreoDent Solidex® Customized Abutment has sufficient mechanical strength for its intended clinical application and is compatible with the specified Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addressed the differences identified when comparing to predicate devices (compatible implant bodies and angulation).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing typically involves a sufficient number of samples to ensure statistical significance for the specific test (e.g., number of abutment-implant assemblies tested for fatigue) but this exact number is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As a non-clinical, in-vitro mechanical testing study, the data is generated in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This is a mechanical testing study, not one requiring expert human interpretation of medical images or patient data to establish ground truth. Therefore, this information is not applicable and not provided. The "ground truth" here is the physical performance of the device under defined test conditions per international standards.
4. Adjudication Method for the Test Set
- Not applicable. As a mechanical testing study, adjudication of human interpretations is not involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic or prognostic algorithms read by human experts, which is not relevant for this dental implant abutment.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
- Not applicable. This device is a physical medical device (an abutment for dental implants), not a software algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance evaluation is established through physical measurements and adherence to international mechanical testing standards (ISO 14801:2007E). The benchmarks are defined by these standards, the performance of the legally marketed predicate devices, and the physical properties of the materials and design.
8. Sample Size for the Training Set
- Not applicable. This is a physical device, and the validation process described is for its mechanical integrity and compatibility, not for an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for a physical device like this.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)