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KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

• Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
• Sirona TiBase
• . KATANA Zirconia ONE mesostructured blocks

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

• Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

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

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
• Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
• Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
• Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
• Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm 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 this type of device.

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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

This document describes the premarket notification for the KATANA Zirconia Block and demonstrates its substantial equivalence to previously cleared predicate and reference devices.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a table (Table 3-6-3) comparing the subject device (KATANA Zirconia Block (14Z L)), the predicate device (KATANA Zirconia Block (12Z, 14Z)), and the reference device (KATANA Zirconia Disc (ST, STML)) against requirements specified in ISO 6872:2015 (Dentistry — Ceramic materials — Part 1: Dental ceramics).

"COMPLIES" indicates that the test value was within the acceptable range to pass the testing in compliance with the requirements of ISO 6872:2015.

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

The document does not explicitly state the sample sizes used for the bench testing. It refers to a "comparative study performed according to ISO 6872:2015," which typically involves specific sample sizes dictated by the standard for each test. The data provenance (country of origin, retrospective/prospective) is not mentioned. However, the applicant is "Kuraray Noritake Dental Inc." in Japan, suggesting the testing was likely conducted by or for this Japanese company.

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 is a physical/mechanical properties test for a dental ceramic block, not a diagnostic medical device that requires expert interpretation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth based on clinical evaluation. The ground truth for these tests is established by adhering to the standards and methods outlined in ISO 6872:2015. Visual inspections (e.g., for uniformity, absence of extraneous materials) would be performed by trained technicians or quality control personnel.

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

Since this is a bench testing scenario focusing on physical and chemical properties against a standard, an adjudication method for conflicting expert opinions (like 2+1 or 3+1) is not applicable. The compliance is determined by instrumental measurements and visual inspections against quantitative and qualitative criteria defined by ISO 6872:2015.

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 MRMC comparative effectiveness study was performed. This device is a dental material (zirconia block) and not an AI-powered diagnostic tool requiring human reader assistance.

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

This is not an algorithm-based device. It is a physical dental material. Therefore, no standalone algorithm performance study was done. The performance evaluation is based on standard material testing methods.

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

The ground truth for this device's performance evaluation is established by international standards (ISO 6872:2015). The performance is measured against the pre-defined limits and specifications within this standard, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The material is manufactured and tested according to quality control procedures to meet the specified standards.

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

As there is no training set for an algorithm, this question is not applicable.

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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (FCZ crowns, inlays, onlays and veneers).

Not Found

The provided text is a clearance letter from the FDA for a dental device, KATANA Zirconia Block, and indications for its use. It describes the regulatory classification and general controls applicable to the device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other details requested in your prompt.

Therefore, I cannot provide the requested information based on the input text. The text does not describe a study or provide performance metrics for the device.

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KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).

Not Found

This document is a 510(k) clearance letter for the KATANA Zirconia device, a material used for dental restorations. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from this document.

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and regulations.

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KATANA Zirconia is used for fabricating the all-ceramic dental frameworks or FCZ crowns and bridges.

This disc (or block) is designed to provide patients with strong and tough prosthetic dental restorations for anterior and posterior applications.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental device called "KATANA Zirconia." It confirms that the device has been found substantially equivalent to a predicate device for its intended use.

The letter does not provide details about a study with acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. This is a regulatory clearance document, not a clinical study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms market clearance but does not contain the specific study details you've asked for.

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KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental device called "Katana Zirconia." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

• Acceptance criteria or reported device performance metrics in a table.
• Sample sizes for test or training sets, nor their provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or technical specification outlining testing details. Therefore, I cannot provide the requested information based on the input text.

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