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510(k) Data Aggregation
(173 days)
Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.
Bonafix Abutment Solutions are a dental implant abutments system that includes three abutment design types (Temporary, Straight Ti-Base and Multi-Unit), that can be used to support single-unit or multi-unit prosthetic restorations. These abutments incorporating interface features compatible with sixteen (16) endosseous dental implant system platforms (Eight (8) designs from five (5) manufactures). The subject device abutments platform diameters range from 3.5mm to 6.3mm, and the corresponding compatible implant body diameters also range from 3.5 mm to 6.3mm. The system also includes corresponding abutment screws.
Temporary Abutments are manufactured from Titanium Grade 5 and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a prosthetic screw which is also manufactured from Titanium Grade 5. The prosthetic screw is delivered with the abutment. Angular correction of temporary abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Modifications can be made by the end-user only in the minimum post height. Minimum post height – 4.0 mm. Temporary Abutments have a maximum duration of usage of 180 days.
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The superstructure are fabricated using a CAD/CAM process in Zirconia. The apical end is prefabricated to fit the compatible implant platform, as shown above, and is available with implant connections for crowns (with socket) or bridges (without socket). Angular correction of abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Each abutment is provided with a screw designed to fit the compatible implant. The design parameters for the fabrication of the zirconia superstructure, which are already locked in the CAD/CAM software, are as follows: Minimum wall thickness – 0.45 mm, Minimum abutment post height – 4.0 mm, Maximum abutment post height – 6.5mm, Maximum gingival height – 5.0 mm, Minimum gingival height – 0.7 mm, Angulation – 0°. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. The required cement for bonding the zirconia superstructure to the Bonafix TiBase abutments to create the final two-piece abutment is G-CEM LinkAce™ cleared in K120243. Bonafix Ti-Base Abutments are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) with the superstructure made of zirconia conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The Multi-unit abutments are screw-attached to the implant to restore fully or partially edentulous arches. Their use is not intended for single-unit crowns. They are designed with various gingival heights (1.5, 2.5 and 3.5mm) and can be screwed directly to a compatible implant. They use a titanium Multi-unit sleeve, which is cemented to the prosthesis. Together with a titanium prosthetic screw, the prosthesis is ready to be screwed onto the Multi-unit abutment, which in turn is screwed onto the implant, thus completing the restoration. This multi-unit abutments are not intended to provide angle or divergence correction. For all system, are manufactured from Titanium Grade 5. Multi-unit sleeve can only be modified in the post height and that the minimum post height is 4mm from gingival collar.
The Prosthetic screw is used to seat all abutments for the system, included the temporary abutments and ti-bases, to the dental implant. They are provided along the prosthetic components, but they are also provided as standalone screws. The Abutment screws are manufactured from titanium alloy conforming to ASTM F136.
All system abutments are provided non-sterile with instructions for end user steam sterilization. The subject devices are provided non-sterile and required to be sterilized. All Bonafix TiBase abutments are packaged into PET bag.
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(400 days)
Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.
The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.
The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.
Therefore, the input document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.
The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.
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(393 days)
Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.
The current submission requests clearance for the Class II Bonafix 2 Plus implant system. The Bonafix 2 Plus Implant is a bone level type implant, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. The implant has a conventional internal hex connection style. The crestal zone of implant have micro-rings. The design crestal zone (straight or tapered) depends on Implant diameter because the implant system has only one platform. The body of the implant is tapered, designed with a double progressive thread with a small internal channel at the bottom of the thread; and the apex of the implant has a flat shape. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant.
The implants are provided in several different dimensions, 3.5, 3.75, 4.2, 5.0, and 6.0mm of diameter, and lengths of 8, 10, 11.5, 13 and 16mm. Hex Connection 6.0 diameter implants do not come in 13 or 16mm length.
Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.
The FDA 510(k) summary for the Bonafix 2 Plus implant system does not contain the level of detail regarding device performance metrics that you are requesting for a typical AI or software as a medical device (SaMD) study.
This document describes a premarket notification for a Class II medical device, which is an endosseous dental implant. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against quantitative acceptance criteria in a clinical study as would be done for an AI/SaMD product.
Here’s a breakdown of why I cannot fulfill your request as phrased, and what information is available:
The document does not describe a study that proves the device meets specific performance acceptance criteria in the way an AI/SaMD device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and material analysis.
Missing Information (for an AI/SaMD context):
- Table of Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or AUC) typically used for AI/SaMD, nor does it report such performance for the Bonafix 2 Plus. The "performance" here is related to mechanical and biological properties demonstrating equivalence to existing devices.
- Sample size used for the test set and data provenance: No test set is described in the context of an AI/SaMD study.
- Number of experts used to establish ground truth & qualifications: Not applicable, as there's no diagnostic AI component requiring ground truth establishment by experts.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. There is no AI component for human-in-the-loop performance evaluation.
- Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable. This is a physical medical device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide, reframed:
The "acceptance criteria" for this device are largely implied through meeting established industry standards for mechanical properties, biocompatibility, and sterilization, and demonstrating that any differences from predicate devices do not raise new safety or effectiveness concerns.
1. "Acceptance Criteria" (Implied by Standards) and "Reported Device Performance":
Since the "acceptance criteria" are not quantitative performance metrics in the AI/SaMD sense, I will list the standards to which the device was tested and the conclusion of those tests regarding "performance" relative to the predicate.
| Category | Acceptance Criteria (Implicit via Standards) | Reported Device Performance / Conclusion |
|---|---|---|
| Fatigue Endurance | Compliance with ISO 14801:2016 and FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants. | "A testing has been conducted to substantiate sufficient fatigue endurance limits for the Bonafix 2 Plus Implants for placement in the anterior and posterior regions of the mouth with compatible abutments. The worst-case scenario for the subject devices has demonstrated substantially equivalent to others device legally marketed regard to mechanical performance." |
| Material Composition | ASTM F136 (Ti-6Al-4V ELI) | Implants are built in Grade 5 ELI Titanium Alloy (Ti-6Al-4V ELI (ASTM F136)). |
| Surface Treatment Integrity | Absence of residual blast media particles on the device. | "SEM/EDS analysis for worst-case representative implant body was conducted... has demonstrated that after the surface treatment the implant doesn't have any different components than Titanium alloy ASTM F 136." |
| Biocompatibility | Compliance with ISO 10993-1 and current FDA guidance (Sept 2020). | "Concluded that the Bonafix 2 plus Implants are substantially equivalent to the predicate devices in terms of biocompatibility inclusive of base materials, manufacturing processes inclusive of surface treatments." |
| Sterilization (Implants) | Sterility Assurance Level (SAL) of 10-6 via ISO 11137-1 and 11137-2. | "Radiation sterilization validation... demonstrating a sterility assurance level (SAL) of 10-6." |
| Sterilization (Abutments) | Sterility via ISO 17665-1. | "Steam sterilization validation... demonstrating a sterility assurance of sterilization protocol of abutment." |
| Shelf Life | Demonstrated shelf life. | "Accelerated aging study demonstrating a shelf life of one (5) year." (Note: The text states "one (5) year," possibly a typo meaning "five (5) years.") |
| Pyrogenicity | LAL Endotoxin Analysis with testing limit of 20 EU/device. | "Pyrogenicity information provided is based on FDA Guidance... The method to be used... is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." This test will be conducted on every batch. |
| Packaging Integrity | Compliance with ASTM F2096-11, ASTM F88, ISO 11607-1. | Bench tests were conducted to verify design specifications and substantial equivalence regarding packaging. (Specific results not detailed in summary). |
2. Sample Size for Test Set and Data Provenance:
- Test Set Description: The document describes non-clinical bench testing on devices, not a test set of patient data.
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for the validation of each standard (e.g., number of implants for fatigue testing, number of samples for SEM/EDS, etc.).
- Data Provenance: The "data" comes from bench tests conducted by the manufacturer, not from retrospective or prospective patient data from specific countries.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable as this is not an AI/SaMD device requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established scientific principles and standard requirements (e.g., proper material composition, the ability to withstand a certain load, sterilization effectiveness).
4. Adjudication Method:
- Not applicable.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This is a physical dental implant, not an AI system.
6. Standalone Performance (Algorithm Only):
- No. This refers to the performance of the physical device in bench tests against established standards.
7. Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is defined by the validated and established scientific standards and testing protocols (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility, ISO 11137 for radiation sterilization). It's not expert consensus, pathology, or outcomes data in the typical AI/SaMD context.
8. Sample Size for the Training Set:
- Not applicable. There is no AI model or training set discussed.
9. How Ground Truth for the Training Set Was Established:
- Not applicable.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (dental implant). It demonstrates substantial equivalence to existing devices through a series of non-clinical bench tests conforming to recognized standards, rather than through comparative clinical performance studies or specific performance metrics typical of AI/SaMD.
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