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Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.

Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.

The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.

The Franz Zirconia Dental Crown is a dental prosthesis for partially edentulous patients to restore chewing function. It is a single crown cemented to an artificial or natural tooth abutment.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance:

Note: The device is considered substantially equivalent to the predicate device despite a minor technological difference in manufacturing method (3D-printing vs. CNC milling) because the performance data demonstrates it performs as safely and effectively as the predicate, raising no new questions of safety and effectiveness.

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes for the mechanical and biocompatibility tests. However, standard testing procedures typically involve a sufficient number of samples to ensure statistical significance for each parameter. The data provenance is not explicitly stated in terms of country of origin but is implied to be laboratory testing conducted by Franz Biotech Inc. No information is provided regarding retrospective or prospective studies.

3. Number of Experts and Qualifications:

Not applicable, as this device primarily relies on materials and mechanical testing rather than interpretation by human experts.

4. Adjudication Method:

Not applicable, as this device primarily relies on materials and mechanical testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done, as this is a dental crown device not requiring human interpretation of diagnostic output.

6. Standalone Performance (Algorithm Only):

Not applicable, as this is a physical medical device, not an algorithm. Performance is assessed through mechanical and biocompatibility testing.

7. Type of Ground Truth Used:

The ground truth for the performance testing is based on established international standards and validated material properties:

• Mechanical Testing: ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials. The ground truth is the specified limits and methodologies within this standard.
• Biocompatibility Testing: ISO 10993 series, including ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12. The ground truth is compliance with these recognized biological evaluation standards.

8. Sample Size for Training Set:

Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as this is a physical medical device, not an AI/ML algorithm.

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