(637 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:
- Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
- Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
- Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants
The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) 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:
- . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
- . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
- Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227)
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.
Here's an analysis of the provided text regarding the CreoDent Solidex® Customized Abutment, focusing on acceptance criteria and study details:
Preamble:
This document describes a 510(k) premarket notification for a medical device, the CreoDent Solidex® Customized Abutment. As such, the purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel clinical efficacy or safety standards through extensive clinical trials. The "acceptance criteria" here refer to demonstrating that the new device performs comparably to the predicate device, particularly in terms of mechanical strength and compatibility, and is therefore deemed safe and effective for its intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the "acceptance criteria" and "reported device performance" for this 510(k) submission is the demonstration of similar mechanical properties to predicate devices and compatibility with specific implant systems. The study cited is non-clinical static/fatigue testing in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the test results demonstrate comparable or superior performance to the predicate under the defined standard. The text doesn't provide numerical acceptance thresholds or specific performance metrics from the predicate devices with which to compare. Instead, it makes a qualitative statement that the device has "sufficient mechanical strength."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical strength for intended clinical application (comparable to predicate device, as defined by ISO 14801:2007E). | "These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application." |
| Compatibility with specific Nobel Replace™ TiUnite Endosseous implant system (as defined by ISO 14801:2007E results). | "and are compatible with the Nobel Replace™ TiUnite Endosseous implant system for which they are intended." |
| Compatibility with specific Nobel Active™ Internal Connection implant system (as defined by ISO 14801:2007E results). | "These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Nobel Active™ Internal Connection implant system for which they are intended." |
| Compatibility with specific Zimmer Tapered Screw-Vent implant system (as defined by ISO 14801:2007E results). | "These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Zimmer Tapered Screw-Vent implant system for which they are intended." |
| Material composition (CP Ti Gr4 unalloyed titanium for abutment, Ti-6Al-4V Eli titanium alloy for screw) comparable to predicate. | Reported materials match the description in the predicate comparison tables (e.g., "Abutment: CP Ti Gr4 unalloyed titanium for surgical implants applications meets ASTM F67/Gr 04-06 Standard - Abutment Screw: Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard"). Predicates use "Comparable Titanium alloy." |
| Indications for Use, Performance Characteristics (cemented or screw-retained prosthesis, abutment screw secures abutment to implant), Dimensions, and Angulations comparable to predicate. | Detailed comparison tables explicitly state that the device's Indications for Use, Performance Characteristics, Dimensions, and Angulations are comparable or the same as the predicate devices. |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact number of units tested. ISO 14801 typically defines sample sizes (e.g., n=5 or n=10 per group). The phrase "worst case scenario for the Solidex® Customized Abutment connection platform" suggests that specific configurations were selected for testing. Without the full test report, the precise sample size is unknown.
- Data Provenance: Not explicitly stated, but as a premarket notification to the US FDA, the testing was likely conducted in an accredited lab, potentially within the US or a country with recognized testing standards. This would be a prospective set of tests designed specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable to the type of study performed. The study was a non-clinical mechanical engineering test (static/fatigue testing) following an international standard (ISO 14801:2007E). The "ground truth" is established by the standardized test methodology and objective measurements, not by expert consensus on clinical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This was a non-clinical mechanical test with objective measurements guided by a standard.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in its primary function or assessment for this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this question is not applicable. This device is a physical medical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this non-clinical study is defined by the ISO 14801:2007E standard itself, which provides a scientifically validated methodology for dynamic fatigue testing of dental implants. The "truth" is the objective measurement of load cycles to failure, maximum force, stiffness, etc., as determined by the specified test method. It's an engineering ground truth, not a biological or clinical one based on consensus or pathology.
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The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing for demonstrating substantial equivalence. The device design and manufacturing processes are established based on engineering principles and materials science, not machine learning or AI training.
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How the ground truth for the training set was established:
- This question is not applicable as there is no training set.
§ 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.)