(188 days)
The CreoDent Solidex® Customized Abutment and Screw 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 and Screw are compatible with the following:
- Sweden & Martina Premium Implant System 3.3mm and 3.8mm
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. Solidex® Customized Abutment and Screw are compatible with:
- Sweden & Martina Premium Implant System 3.3mm and 3.8mm
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 CreoDent Solidex® Customized Abutment and Screw is a dental device intended for use with endosseous implants to support prosthetic devices. The information provided outlines the acceptance criteria and the study that proves the device meets these criteria as part of a 510(k) premarket notification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance | Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. |
| Mechanical Strength (Fatigue Testing) | Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst-case scenario. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application. |
| Dimensional Analysis (Compatibility) | Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. The device is compatible with Sweden & Martina Premium Implant System 3.3mm and 3.8mm (specific implant diameters and lengths as detailed in the document). |
| Sterilization Efficacy | Sterilization was conducted according to ISO 17665-1. (Detailed results not provided, but the statement implies successful completion). |
| Biocompatibility | Biocompatibility information is leveraged from their previous 510(k) (K150012). (Implicitly, the device material has been proven biocompatible in a prior submission). |
| Angle Limitation | Angles not to exceed up to 20 degrees from the implant axis (for customized abutments). |
| Substantial Equivalence (Overall) | The CreoDent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate products (Creodent Solidex Customized Abutment (K150012) and Sweden & Martina Premium Implant System (K142242)) in intended use, material, design, and performance, with differences mitigated by testing. The differences in compatible implant bodies compared to their primary predicate were mitigated through dynamic fatigue testing and 300-party compatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in terms of a patient population size for clinical data. The testing described is primarily non-clinical:
- Non-clinical Testing Data: Static/Fatigue testing in accordance with ISO 14801:2007E. The sample sizes for these mechanical tests are not specified (e.g., number of abutments and screws tested).
- Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. The number of samples for this analysis is not specified.
The data provenance is from non-clinical laboratory testing and reverse engineering dimensional analysis, rather than patient-derived data from a specific country, and is therefore not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies described are non-clinical (mechanical and dimensional testing) and do not involve human expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests would be the established engineering standards (e.g., ISO 14801:2007E), and the manufacturing specifications for the device and compatible implants.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated above. There was no "test set" 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. The submission focuses on the mechanical and material equivalence of a dental abutment and screw to an existing predicate device using non-clinical testing. It does not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical medical device (dental abutment and screw), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on:
- Industry Standards: ISO 14801:2007E for dynamic fatigue testing.
- Manufacturer Specifications: OEM implant bodies, OEM abutments, and OEM abutment screws for reverse engineering dimensional analysis.
- Regulatory Standards: ASTM F-136 for material composition (Ti-6A1-4V Eli titanium alloy).
- Previous Biocompatibility Data: Leveraged from their previous 510(k) (K150012).
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical dental implant component, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above.
§ 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.)