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IPS e.max® CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• IPS e.max CAD ceramic structure
• Ti base
• CAD/CAM system.

The IPS e.max CAD ceramic structure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The compatible Implant systems, titanium bases and CAD/CAM systems are shown below: -Implant Systems:

• Dentsply Sirona: AstraTech OsseoSpeed, Frialit/Xive (K130999, K013867)

• BioHorizons Implant System: Internal Connection (K143022, K071638, K093321, K042429),

• Osstem: TS Implant System (K121585)

• Straumann: Tissue Level RN/WN (K061176)

• Nobel Biocare: Branemark (K022562)

• Zimmer: Tapered Screw-Vent (K061410)

• Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991)

• CAD/CAM Systems: Sirona Dental CAD/CAM System (K181520)

-Titanium Bases: Dentsply Sirona TiBase, Camlog TiBase

The IPS e.max® CAD Abutment Solutions- extra systems Device Description: which is the subject of this premarket notification is a modification to the IPS e.max CAD Abutment Solutions as previously cleared under K132209. The modifications represented in the subject device consist of the addition of 11 extra Ti-Bases to the 4 previously cleared Ti-Base compatibilities.

IPS e.max CAD Abutment Solutions- extra systems is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. IPS e.max CAD Abutment Solutions is a system comprising IPS e.max CAD ceramic structure, Sirona TiBase and Sirona CAD/CAM System to design and fabricate the ceramic structure. The abutments being two-piece titanium base abutments are mated with a ceramic top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.

For the fabrication of IPS e.max CAD Abutment Solutions and depending on the CAD/CAM system used, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan. Updated material and TiBase library datasets relating to Sirona Dental CAD/CAM System with CEREC chairside software are obtained by download at: https://my.cerec.com.

IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. The connection geometry fit select Titanium Bases as identified in the Indications for Use. The mesostructured is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown. The device serves as the esthetic mesostructured which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

The document describes the regulatory submission for the IPS e.max® CAD Abutment Solutions- extra systems (K191382). This device is a modification of a previously cleared device (K132209) and primarily focuses on the addition of new compatible titanium bases for various implant systems.

The acceptance criteria and study information are derived from the "Testing Summary" and "Conclusion" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses the substantial equivalence of the modified device to its predicate, focusing on adding new compatible implant systems. The primary performance characteristic assessed is fatigue strength.

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

The document states, "The fatigue testing performed for the listed extra systems proves that IPS e.max CAD Abutment Solutions can be used with the 11 additional implant systems." However, specific sample sizes (e.g., number of test specimens per implant system) are not explicitly provided in the provided text for the fatigue testing. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The type of testing described (dynamic fatigue) is a bench-top mechanical test, not reliant on expert evaluation for ground truth in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is a bench-top mechanical fatigue test, not a clinical study involving human readers or interpretation requiring adjudication.

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 is not applicable. The device is an endosseous dental implant abutment system, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical medical device (dental abutment system), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation in this context is based on mechanical endurance testing (fatigue strength) as defined by the ISO 14801:2007 standard.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable for the same reason as above.

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