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DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The proposed DS (Dentsply Sirona) Implants abutments with EV connection are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches.
The proposed devices in this bundled 510(k), which are included under the same master brand - DS Implants abutments with EV connection, include:
(A) Cover Screw EV, Healing Abutment EV, HealDesign EV, Temp Abutment EV, TiDesign EV, CastDesign EV, Abutment Screw EV, and
(B) MultiBase Abutment EV and its accessory components including the Multibase heal cap. MultiBase temporary cylinder, MultiBase semi-burnout cylinder, and MultiBase bridge screw.

This document is a 510(k) summary for Dentsply Sirona's DS Implants abutments with EV connection. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria or conducting studies to prove performance against specific criteria for a novel device. Therefore, much of the requested information about acceptance criteria and a study proving a device meets them is not directly available in this document.

However, based on the provided text, we can infer some aspects related to performance and substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit acceptance criteria in a table format. Instead, it relies on demonstrating that the proposed devices are substantially equivalent to existing predicate devices, meaning they perform as intended and similarly to the cleared devices. The key performance aspect discussed is fatigue performance.

• Implied Acceptance Criteria (Fatigue Performance): The proposed DS Implants abutments must exhibit fatigue performance equivalent to or better than the identified worst-case predicate abutment (MultiBase Abutment EV, 30°).
• Reported Device Performance (Fatigue Performance): The document states: "The fatigue test results obtained with the existing worst-case abutment together with the compatible implants with EV connection... indicate that the proposed DS Implants abutments with EV connection (A) and (B) perform as intended." This implies that the performance meets the established safety and effectiveness levels of the predicate devices.

Other performance aspects implicitly covered by substantial equivalence include biocompatibility and sterilization efficacy, which are assumed to be met if the proposed device's characteristics are similar or validated against existing standards and predicate devices.

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 explicitly states: "Therefore, no new fatigue performance data is provided in this submission in support of substantial equivalence." This means there was no new test set for fatigue performance for this submission. The data provenance for the original fatigue testing of the predicate device (MultiBase Abutment EV, 30°) is not specified, nor is whether it was prospective or retrospective.

For biocompatibility, a "review of existing cytotoxicity testing on file for reference device Friadent Aurobase Abutment D3.0 (K030639)" was performed. No sample size for this review is mentioned.

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 provided as the submission relies on previously conducted tests and established equivalency, not on a new ground truth assessment by experts for the current device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there was no new test set involving human assessment or adjudication for this 510(k) submission.

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

This aspect is not applicable. The device is an endosseous dental implant abutment, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This aspect is not applicable for the same reason as point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For fatigue performance, the ground truth would be established through mechanical testing compliant with recognized standards (e.g., ISO standards mentioned for sterilization, implying similar rigorous standards for mechanical tests like fatigue). For biocompatibility, it's based on cytotoxicity testing and compliance with ISO 10993-1:2018. The document implicitly relies on these established standards as "ground truth" for safe and effective performance.

8. The sample size for the training set

This information is not applicable as this is a medical device clearance, not an AI/algorithm submission requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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