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The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
• The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.

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 (A) OmniTaper EV Dental Implants are root form endosseous implants intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. The proposed (A) OmniTaper EV Dental Implants have the identical implant-abutment connection geometry as predicate (A) Astra Tech EV Implants (K120414). The proposed (A) OmniTaper EV Dental Implants are therefore compatible with the Astra Tech EV Abutments (K120414).

The proposed (B) DS Implant abutments with EV connection include the following abutments and accessories:

• TempBase EV, and its accessory component TempBase Cap
• Cover Screw EV
• Healing Abutment EV
• HealDesign EV
• TempAbutment EV
• TiDesign EV
• CastDesign EV
• MultiBase Abutment EV
• Abutment Screw EV

The proposed (B) DS 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. They are prosthetic abutments that are:

• Compatible with the proposed (A) OmniTaper EV implants,
• Represent an additional abutment type (TempBase EV abutment and cap),
• Introduce additional abutment sizes (XS Extra Small and XL Extra Large) to the predicate (B) DS Implants abutments with EV Connection in sizes S (Small), M (Medium) and L (Large) (K213449).

The proposed (B) DS Implant abutments with EV connection have the identical implantabutment connection geometry as predicate (B) DS Implants abutments with EV connection (K213449) and the Astra Tech EV Abutments (K120414), and are therefore also compatible with predicate (A) Astra Tech EV Implants (K120414).

The proposed (A) OmniTaper EV Dental Implants and proposed (B) DS Implants abutments with EV connection are single-use devices.

The proposed (A) OmniTaper EV implant with pre-mounted proposed (B) TempBase EV abutment, and the proposed (B) devices Cover Screw EV, Healing Abutment EV, HealDesign EV and (B) Multibase Abutment EV are provided sterile via Electronic-Beam (E-beam) irradiation.

The proposed (B) TiDesign EV, CastDesign EV, TempAbutment EV, TempBase Cap and Abutment Screw are provided non-sterile. Devices provided non-sterile are to be sterilized via steam sterilization, or as in the case of the TempBase Cap, cleaned/disinfected, by the end user prior to use per the Instructions for Use.

This response addresses the requested information based on the provided text, but it's important to note that the document describes a dental implant and abutment system, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable and will be marked as "Not Applicable (N/A)".

Device Name: OmniTaper EV Dental Implants and DS Implants abutments with EV connection

Device Type: Endosseous Dental Implants and Abutments

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the "acceptance criteria" are demonstrated through substantial equivalence to predicate and reference devices, supported by non-clinical performance data (e.g., sterilization, biocompatibility, fatigue, MRI testing) and clinical literature review. There are no explicit performance metrics in the format of a typical diagnostic device's acceptance criteria, but rather a demonstration that the new devices are as safe and effective as existing legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Non-Clinical Test Set: The document describes various non-clinical tests (sterilization, biocompatibility, fatigue, MRI) but does not specify numerical sample sizes for these tests. It indicates that "worst-case" implant-abutment combinations were tested. The provenance of this data is internal to Dentsply Sirona or their contracted labs, as it states "Non-clinical testing data submitted, referenced, or relied upon..."
• Clinical Literature Review (Test Set): For the clinical relevance of the Ø3.0 implant, four peer-reviewed scientific publications were referenced. These studies presented 1 to 4 years of prospective clinical follow-up data on over 580 Xive S Plus D 3.0 implants. The country of origin for these publications is not specified, but they are peer-reviewed scientific literature.

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)

N/A. This device is a dental implant system, not a diagnostic AI device requiring expert-established ground truth for a test set. Clinical relevance was supported by published peer-reviewed literature.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

N/A. This information is for AI performance evaluation. The device is a physical medical device.

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

• Non-Clinical Testing: Ground truth is established by standardized testing protocols and existing predicate device performance, ensuring properties like sterility, biocompatibility, and mechanical strength meet established engineering and safety standards.
• Clinical Literature Review: The clinical "ground truth" for the 3.0mm implant's effectiveness and safety (survival rates, stable marginal bone) is derived from outcomes data reported in multiple peer-reviewed scientific publications with prospective clinical follow-up.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. Its development and validation rely on engineering design, materials science, and non-clinical testing, followed by comparisons to predicate devices and review of existing clinical literature.

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

N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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