Search Results
Found 1 results
510(k) Data Aggregation
(186 days)
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut)
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
The Omnibut™ is a transmucosal abutment used to support screw-retained prostheses on four or more implants. The subject device has a premanufactured connection for the platforms listed in Table 1 Compatible Implant Systems.
The system involves a ball abutment attached to an implant. A retention attachment allows for angle corrections of up to 30° off the implant axis. The ball abutment is inserted into the attachment is adjusted to the desired angle using an orientation screw. The abutment supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. Finally, the prostheses are retained to the abutment by prosthetic screws.
The subject device abutments and system components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. The subject device is a single use device is provided nonsterile and intended to be sterilized by the user prior to placement in the patient.
Here's a breakdown of the acceptance criteria and study information for the Omni-Directional Multi-unit Abutment System (Omnibut™), based on the provided FDA 510(k) summary:
Description of the Device
The Omnibut™ is a pre-manufactured prosthetic component directly connected to endosseous dental implants. It is intended for use as an aid in prosthetic rehabilitation, specifically for supporting screw-retained prostheses on four or more implants. The system includes a ball abutment attached to an implant, with a retention attachment allowing for angle corrections of up to 30° off the implant axis. It supports prostheses that connect via titanium cylinders, which are incorporated into resin or ceramic prostheses. The device is made from Ti-6Al-4V alloy and is provided non-sterile, requiring user sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Description of Test | Reported Device Performance (Results) |
|---|---|---|
| Biological Evaluation | ||
| ISO 10993-1:2018; FDA Guidance on the Use of ISO 10993-1, 2023 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | PASS – All biological endpoint testing performed on the device, along with the analysis on the physical and chemical information, returned passing results. All biological endpoint testing suggests that the Omnibut is biocompatible and does not present a foreseen biological risk to those patient populations it is intended for. |
| ISO 10993-5 (2009) | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | PASS – The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test since the grade was grade 0 (no reactivity). |
| Sterilization Validation | ||
| AAMI TIR12:2020; ANSI/AAMI/ISO 17665-1:2026/(R)2013; ANSI/AAMI ST79:2017 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A Guide For Device Manufacturers, Overkill method according to Section 5.7 | PASS – Results from testing have demonstrated that the Omnibut was able to achieve a 10-6 SAL when using the recommended parameters in the Instructions for Use (IFU). |
| Mechanical Performance | ||
| ISO 14801:2016; FDA Guidance Document, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) Section 8 | Dentistry — Implants — Dynamic loading test for endosseous dental implants | PASS – The results conclude that when evaluated in a manner consistent with ISO 14801:2016, the Omnibut met all predetermined acceptance criteria. |
| No specific standard (Compatibility) | Reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws were performed to demonstrate that the Omnibut abutments are compatible with the noted implant systems. Compatibility must be demonstrated to ensure proper device functionality. | PASS – The engineering and dimensional analysis concluded that each Omnibut design is compatible with the applicable implant connection. PASS - Omnibut prosthetic side components were demonstrated to be compatible. |
| No specific standard (Retention Force Testing) | The Omnibut has a retention attachment. Retention Force testing was performed via tensile push-out to ensure that the attachment will not detach during clinical use. | PASS – The Omnibut retention attachment did not detach at a predetermined acceptable force. |
| No specific standard (Simulated-Use Testing) | Simulated Use of four Omnibuts with components connected to a Titanium Bar under a clinically relevant cyclic load. | PASS – The Omnibut and components did not yield, deform, or fracture after fatigue testing. |
| No specific standard (Simulated Cleaning Testing) | Simulated cleaning of Omnibuts in a fixture with a clinically worst case cleansibility construction. | PASS – All parts of the Omnibuts were clean of soil indicators after six soilage and cleaning cycles. |
| MR Safety | ||
| FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis to evaluate the subject device in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795). | The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. The document does not explicitly state the results (e.g., "MR Safe" or "MR Compatible"), but implies that the analysis was sufficient to support safety in the MR environment based on the scientific rationale and literature used. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each individual non-clinical test (e.g., number of abutments tested for dynamic fatigue, retention force, simulated use, or cleaning). It refers to the testing as "non-clinical" bench testing.
- Test Set Provenance: The data is generated from bench testing (laboratory studies), not from clinical data involving human patients. Therefore, information like "country of origin of the data" or "retrospective/prospective" is not applicable in the typical sense of clinical trials. The testing was performed in vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical bench tests. The "ground truth" for these tests is based on established engineering standards (e.g., ISO 14801), biological evaluation standards (ISO 10993), and internal company protocols for mechanical and cleaning validation, not on expert clinical interpretation of patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the studies are non-clinical bench tests. Adjudication methods are typically employed in studies involving human interpretation or clinical endpoints to resolve discrepancies in assessment.
5. 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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers/interpreters, which is not the case for this dental implant abutment. The device is a physical component, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This question is relevant for AI/software devices; this device is a physical medical device. The "standalone" performance here refers to the device's mechanical and biological performance on its own, which is what the bench tests evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance evaluations relies on:
- Established engineering and biological standards: e.g., ISO 14801:2016 for dynamic fatigue, ISO 10993 for biocompatibility, ANSI/AAMI/ISO for sterilization.
- Predetermined acceptance criteria: For retention force, simulated use, and cleaning efficacy, the "ground truth" is defined by specific pass/fail criteria established during the test design based on expected clinical performance and safety.
- Dimensional accuracy and compatibility models: For compatibility testing, the "ground truth" is established by the dimensions and specifications of OEM implant bodies and abutments.
8. The Sample Size for the Training Set
This information is not applicable because the device is a physical medical component, not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
Ask a specific question about this device
Page 1 of 1