(308 days)
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The subject devices comprise the metallic endosseous dental implant abutments and metallic prosthetic superstructures cleared to market in the United States as of December 15, 2017 under K170838, K150203, and K142167 by Medentika GmbH as part of the Medentika Multi-Platform System.
Medentika Multi-Platform System is an abutment system including eleven abutment designs compatible with twelve currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21°.
The TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.
The assessment of these devices in the MR environment has not resulted in any changes to the devices themselves. The proposed labeling change provides the parameters under which a patient having a restoration constructed using the devices of the Medentika Multi-Platform System can safely undergo an MRI scan.
The stock endossoues dental implant abutments are fabricated from titanium-aluminumvanadium (TAV) alloy and noble metal alloys. The CADCAM abutments are fabricated from commercially pure titanium. The materials for the TiBase copings and/or crowns include zerion and IPS e.max CAD.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| MR Conditional designation | The Medentika Multi-Platform System (including Medentika Abutment System, Medentika CAD/CAM Abutments, and Medentika CAD/CAM TiBases) is MR Conditional. |
| Static magnetic field for safe scanning | 1.5 Tesla and 3 Tesla, only |
| Maximum spatial gradient magnetic field for safe scanning | 4,000 gauss/cm (40 T/m) |
| Maximum whole body averaged Specific Absorption Rate (SAR) for safe scanning | 2 W/kg (for 15 minutes of scanning per pulse sequence) |
| Maximum head averaged SAR for safe scanning | 3.2 W/kg (for 15 minutes of scanning per pulse sequence) |
| Maximum temperature rise after 15 minutes of continuous scanning (per pulse sequence) | 4.9°C |
| Extent of image artifact (when imaged with a gradient echo pulse sequence and a 3 Tesla MR system) | Approximately 10 mm from the device |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical testing performed on the device itself to establish its MR compatibility. It does not refer to a "test set" in the context of clinical data (e.g., patient images). Therefore, clinical sample size and data provenance (country of origin, retrospective/prospective) are not applicable here. The testing involved various configurations of the metallic implantable devices of the Medentika Multi-Platform System (worst-case constructs).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The study is a non-clinical, laboratory-based assessment of device physical properties in an MR environment, not a study involving human interpretation of medical images. The "ground truth" here is derived from standardized testing methods as outlined by ASTM and FDA guidance.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study examines the device's physical compatibility with MRI, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This study is a non-clinical evaluation of the device's physical properties, not an algorithm's performance.
7. Type of Ground Truth Used
The ground truth for this study is based on physical measurements and standardized tests according to established guidelines and standards:
- FDA Guidance entitled "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" (August 2014)
- FDA Guidance document entitled "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" (June 29, 2015)
- ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment
- Shellock, et al. procedure for torsional force (accepted as an alternative to ASTM F2213-06 (2011))
- ASTM F2182-11a: Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2119-13: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
8. Sample Size for the Training Set
This information is not applicable as this is a non-clinical device safety study, not a machine learning model development or validation study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.)