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Tapered Screw-Vent Zimmer Dental Implant: Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer One-Piece (ZOP) Dental Implant: Zimmer One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor, and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer One-Piece Implant must be splinted if two or more are used adjacent to each other. The Zimmer One-Piece Implant may be immediately restored with a temporary prosthesis that is not in functional occlusion

Screw-Vent Zimmer Dental Implant: Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

Advent Zimmer Dental Implant: Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

SwissPlus Dental Implant: Zimmer Dental implant systems are designed for use in endentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

Spline Twist Dental Implant: Zimmer Dental implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

Trabecular Metal Implant™ (Tapered Screw Vent® X Implant System): Zimmer Dental implant systems are (Tapered Screw Vent® X Implant System) designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.7mmD Trabecular Metal Implants should be splinted to additional implants when used in the pre- molar region and should not be used in the molar region. The 4.1mmD Trabecular Metal Implants should be splinted to additional implants when used in the molar region.

Zimmer 3.1mmD Dental Implants: The 3.1mmD Eztetic Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The 3.1mmD Eztetic Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The 3.1mmD Eztetic Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated & Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated: Zimmer dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer Dental Tapered Screw-Vent® T Implant & Zimmer Dental Tapered Screw-Vent® M Implant: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer Contour Hex-Lock Abutment, Straight: Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.

Zimmer Contour Hex-Lock Abutment, 17°: Abutment is used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single or multiple-unit restoration.

Zimmer Dental Inc. Hex-Lock Abutment: Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.

Hex-Lock Short Abutments: Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single or multiple-unit restoration.

Zimmer Dental Inc. 20° Angled Abutment: Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

"Cast-To" Gold Abutments, Engaging: Zimmer Dental Implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System, Engaging: The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.

"Cast-To" Gold Abutments, Non-Engaging: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer Cast-To Gold Abutment for the 3.1mmD Dental Implant System. Non-Engaging: The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System. Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.

2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex: The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.

Angled Tapered Abutments, 15°: The Angled Tapered Abutment is used for a terminal or intermediate abutment for screwretained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45° of parallelism for a splinted restoration.

Angled Tapered Abutments, 30°: The Angled Tapered Abutment is used for a terminal or intermediate abutment for screwretained multiple-unit restorations. The 30° Angled Tapered Abutment must be used within 45°of parallelism for a splinted restoration. The 15° Angled Tapered Abutment must be used within 30° of parallelism for a splinted restoration.

Zimmer Dental Inc. Screw Vent Ball Abutment: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Spline Temporary Abutment: Temporary Abutment, Engaging: Spline engaging titanium alloy cylinder with retentive parallel walls and a flared cuff. Attaches to the Spline Implant with a separate screw. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units. Do not use as a permanent abutment. Not to exceed six weeks of placement. Temporary Abutment, Non-Engaging: Adjustable titanium alloy cylinder with retentive parallel walls and a cuff. Attaches to the Spline Implant with a separate screw. Does not engage the tines. For use when a temporary prosthesis for up to six weeks is desired. Single or multiple units.

Spline Fixed Abutment: For use as a terminal or intermediate abutment for cemented prosthesis. Abutments must be parallel to within 7.5° for Spline Implant or be prepped to be parallel. The Spline Abutments can be used for a single tooth or splinted to other abutments. Single use.

Spline Fixed Abutment, 17°: For use as a terminal or intermediate abutment for cemented prosthetics when long axis of abutment needs to be changed by 15°, 17° or 25°. Abutment can be used for single tooth or splinted restorations. Single use.

Zimmer Zfx Titanium Abutment for NobelActive Implant System: The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm, or Regular Platform (RP) Ø 3.9mm.

Zimmer Zfx Abutment for NobelReplace Implant System: The Zimmer Zfx Abutment for NobelReplace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedyReplace implants with a Narrow Platform (NP) Ø3.5 mm, Regular Platform (RP) Ø 4.3 mm, WidePlatform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0mm.

Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System: The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Platform Connection (NC) Ø 3.3mm or Regular CrossFit Platform Connection (RC) Ø 4.1mm or 4.8mm.

Zimmer Zfx Titanium Base Abutment for Tapered Screw Vent Implant System: The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single -unit or multi-unit(bridge) restoration. The Zimmer Zfx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.

Zimmer Zfx Abutment for Biomet 3i Certain Implant System: Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.

Zimmer® Patient Specific Abutment, Internal Hex, Titanium: The Zimmer Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.

Tapered Screw-Vent Healing Collar: The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

2.9mm Healing Collar: The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

Zimmer Dental Surgical Cover Screw: The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw and Surgical Cover Screw are for single use only.

2.9mm Healing Screw: The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Healing Screw is for single use only.

Retaining Screw: The Retaining Screws are intended to be used for securing the temporary abutments, final abutments, and impression transfers to the implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.

Not Found

This document (K160398) is a 510(k) premarket notification for "MRI Compatibility for Existing Zimmer Dental Implant Systems." It is a regulatory filing, not a study report. Therefore, it does not contain the detailed information you are requesting about acceptance criteria, device performance, ground truth establishment, or study designs (e.g., MRMC).

The document is primarily a list of various Zimmer Dental implant and abutment systems with their indications for use, confirming their MRI compatibility. It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. This implies that the MRI compatibility has been sufficiently demonstrated for regulatory purposes, but the specific studies and their detailed results, acceptance criteria, and ground truth methodologies are not provided in this regulatory letter itself.

To answer your questions, one would need to access the full 510(k) submission, which would contain the test reports and data that the FDA reviewed to make their determination. This publicly available letter only provides a summary of the FDA's decision and the device indications for use.

Therefore, I cannot provide the requested information from the given document as it does not contain the detailed study data.

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The Zimmer® Patient Specific Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.

The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is designed for use with internal hex connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection. The proposed changes to the Zimmer Patient-Specific Abutment include changes to the design parameters with respect to the margin width and radius, the cuff height and the cuff width. The updated design parameters do not affect the device's intended use or alter the fundamental scientific technology of the device.

The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy patient's needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The abutment is offered in 3.5mm, 4.5mm, and 5.7mm implant platforms.

The document does not describe a study involving AI or a comparative effectiveness study with human readers. The device in question is a dental abutment, and its evaluation relies solely on non-clinical performance testing.

Here's the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the non-clinical testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endossesous Dental Implant Abutments." While the specific numerical acceptance criteria (e.g., minimum fatigue strength in Newtons) are not explicitly listed in the provided text, the document indicates compliance with this guidance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text. The document refers to "testing" but does not give the number of samples tested for fatigue, compression, or sterilization validation.
• Data Provenance: Not explicitly stated as retrospective or prospective, but given it's non-clinical lab testing, it would be considered prospective for the specific tests performed. The country of origin of the data is not mentioned but can be inferred as likely from the U.S. based on the applicant's location (Carlsbad, CA) and submission to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a physical medical device (dental abutment), and its performance is evaluated through non-clinical engineering tests (fatigue, compression, sterilization validation, MRI compatibility) rather than through expert-driven ground truth assessment of medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication was involved in the non-clinical engineering tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study described is entirely non-clinical performance testing of a physical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical dental abutment, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing comprises established engineering standards and FDA guidance documents for mechanical performance (fatigue, compression), sterilization efficacy (SAL), and MRI safety. The success of the device is determined by its ability to meet these predefined technical specifications.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical medical device.

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The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration

The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is designed for use with Zimmer 3.1mmD Dental Implants to support single or multi tooth restorations. The new abutment will be offered in a 2.9mm implant platform.

The Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist.

Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V ELI), and secured to the implant with a separate Titanium alloy screw for retention.

This 510(k) premarket notification describes the Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System, a custom dental implant abutment made from Titanium alloy (Ti6Al4V ELI). The submission aims to demonstrate substantial equivalence to a predicate device, the Zimmer Patient-Specific Abutment, Internal Hex, Titanium (K071439).

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it refers to compliance with an FDA guidance document and states that the new device demonstrated improvements over the predicate in certain non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for the fatigue, compression, or sterilization validation tests.
• Data Provenance: The tests were "non-clinical" and performed by Zimmer Dental, Inc. The country of origin for the data is not explicitly stated, but given the company's address in Carlsbad, CA, it's presumed to be the USA. The data is from a prospective testing regimen designed to support the 510(k) submission.

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 study was non-clinical (mechanical, sterilization, and MRI compatibility testing). There was no "ground truth" in the context of expert diagnosis or interpretation of data in the way it's typically understood for AI/medical imaging devices. The "ground truth" for these tests would be the measured physical properties and performance against established engineering and regulatory thresholds.

4. Adjudication Method for the Test Set:

This information is not applicable as the study was non-clinical. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images).

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:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness." This device is an implantable medical device, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical dental implant abutment, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this non-clinical study relied on:

• Engineering Standards and Regulatory Guidance: Performance was evaluated against the "FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments" for mechanical properties and the "FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" for MRI compatibility.
• Analytical Measurement Outcomes: The results of the fatigue, compression, sterilization, and MRI compatibility tests serve as the "ground truth" for whether the device meets the specified performance criteria derived from these standards. For example, a measured force to failure during compression testing provides a numerical ground truth for mechanical strength.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require training sets.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated in point 8.

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