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510(k) Data Aggregation
(93 days)
The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
Device Components:
- Abutment
- Ti-Base
- Master Fix
- Abutment Screw
The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base 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 zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
The provided document is a 510(k) premarket notification for the "Ti-Base & Master Fix" dental implant abutments. It includes a summary of technology characteristics and performance data but does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert opinions, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device (DESS Dental Smart Solutions, K191986) primarily through material composition, intended use, and mechanical testing that mitigates minor design differences.
Therefore, many of the requested details cannot be extracted from this document.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum fracture strength, fatigue life thresholds) or report specific numerical performance outcomes against such criteria for the "Ti-Base & Master Fix" directly.
- It references mechanical performance testing as a method to mitigate differences in design and ensure safety and effectiveness, implying that such tests were conducted and their results were deemed acceptable, but the actual data/criteria are not provided in this summary.
- It also mentions biocompatibility testing according to ISO 10993-5 and ISO 10993-12, and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2. These standards implicitly contain acceptance criteria, but the specific results or criteria are not detailed in this submission summary.
Table of Acceptance Criteria and Reported Device Performance (Based only on what's implicitly mentioned as having been met)
| Acceptance Criteria Category | Acceptance Criteria (Implicit from referenced standards/statements) | Reported Device Performance (Implicit from overall submission) |
|---|---|---|
| Mechanical Performance | Meets performance requirements to ensure safety and effectiveness despite design differences (e.g., fracture strength, fatigue resistance). | Testing was conducted, and differences were mitigated, implying acceptable performance. No specific values or thresholds provided. |
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity) and ISO 10993-12 (sample preparation). | Testing was performed according to these standards, implying compliance. |
| Sterilization | Validated for moist heat sterilization per ISO 17665-1 and ISO 17665-2. | Validation was performed, implying a sterile product post-processing by the end-user. |
| MRI Safety | Evaluation performed for magnetically induced displacement force and torque, per FDA guidance. | Review performed using scientific rationale and published literature, implying acceptable safety in MR environment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide details on sample sizes for mechanical performance testing, biocompatibility, or sterilization validation.
- No information on the country of origin of the data or whether the studies were retrospective or prospective can be extracted.
3. 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 information is not applicable and not provided. The submission is for a medical device (dental implant abutment), and the performance data primarily relates to physical and material properties, not diagnostic imaging or clinical interpretation requiring expert ground truth establishment in that typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. This typically applies to clinical or imaging studies where expert consensus is formed, which is not the type of study described here.
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
- Not applicable and not provided. This is a medical device (dental implant abutment) submission, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For physical device testing, ground truth would typically refer to established engineering standards, material properties, and validated test methods (e.g., ISO standards for mechanical testing, biocompatibility).
8. The sample size for the training set
- Not applicable and not provided. There is no machine learning or AI component described that would require a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided.
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(224 days)
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.
The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Ti-Base abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Nobel Biocare NobelActive TM .
- Biomet 3i® Osseotite® .
- Biomet 3i® Osseotite® Certain® .
- Nobel Biocare Branemark® ●
- Straumann® synOcta® .
- Straumann® Bone Level® .
- Zimmer® Tapered Screw-vent® .
- Astra Tech OsseoSpeed® .
- Dentsply-Friadent® Frialit® .
2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Straumann® synOcta® .
- Straumann® BoneLevel® .
The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation.
The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems must be validated by the user.
This K111935 510(k) submission describes the acceptance criteria and study for the NT-Trading Ti-Base Abutment and 2-CONnect Abutment, which are dental abutments.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Testing) |
|---|---|
| Fatigue Testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants | Fatigue testing was performed on the abutments with the implants they are intended to fit. The results demonstrated compatibility and substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed on the abutments in this submission with the implants that they are intended to fit." However, the exact sample size (number of abutments/implants tested) and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified in the provided 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a medical device (dental abutments) and relies on engineering and performance testing (fatigue testing) rather than a clinical study with a "ground truth" established by human experts in the context of diagnostic performance. Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic studies is not applicable here. The "ground truth" for this device is its physical performance under specified standards.
4. Adjudication Method for the Test Set
As this is a performance study based on engineering standards (fatigue testing), an adjudication method in the context of human expert disagreement is not applicable. The results are based on objective measurements and predefined pass/fail criteria according to ISO 14801.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This is a performance study for a physical device, not a diagnostic or AI-assisted interpretation study. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this study is based on engineering standards and objective physical measurements in a laboratory setting, specifically fatigue testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants.
8. The Sample Size for the Training Set
The provided document describes a device subject to performance testing, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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