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510(k) Data Aggregation
(238 days)
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
| Acceptance Criteria / Performance Aspect | Device Performance / Standards Met |
|---|---|
| Material Composition | Identical to reference device KATANA Zirconia Block (K190436) |
| Biocompatibility | Evaluated per ISO 10993 series and ISO 7405; meets requirements |
| Material Standards (Zirconia Ceramic) | Conforms to ISO 6872:2015 |
| Dynamic Fatigue Test (Implants) | Performed according to ISO 14801:2016 for worst-case representative devices |
| Sterilization | Validated per ISO 17665-1, achieving SAL of at least 10^-6 |
| MR Environment Compatibility | Non-clinical worst-case MRI review performed based on scientific rationale and published literature; addressed magnetic displacement force and torque. |
| CAD/CAM System Compatibility | Confirmed compatible with Sirona Dental CAD/CAM System (K193408, K200191) through a business agreement and disclosed requirements. |
| Abutment Post Height | 4.0 mm ~ 16.7 mm |
| Angulation | 0° ~ 20° (over 20° is contraindication at TiBase) |
| Wall Thickness | 0.8 mm ~ 9.5 mm |
| Diameter | 3.3 mm ~ 6.0 mm (dependent on selected TiBase) |
| Gingival Height | 1.0 mm (dependent on selected TiBase) |
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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(96 days)
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two- piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.
Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Tibase abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.
MIS Ti-base abutments are intended for use with the following MIS implants:
- C1 conical connection implant system
- V3 conical connection implant system
- SEVEN internal hex implant system
- M4 internal hex implant system
- Lance+ internal hex implant system
The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.
MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.
MIS Ti-base abutments are the bottom-half/base of a two-piece custom ceramic-titanium abutment consisting of a ceramic coping/mesostructure and a titanium base.
The top-half custom ceramic coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block, IPS e.max® CAD ceramic block, or from IPS e.max® CAD ceramic block or VITA ENAMIC® (IS) ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm for inCoris ZI and e.max materials and 0.8mm for VITA ENAMIC material.
It is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.
The subject, pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.
This document describes a 510(k) premarket notification for the MIS Ti-base abutment. This is an FDA submission for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and similar technological characteristics. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically demonstrating this substantial equivalence through non-clinical performance data, rather than a clinical trial with specific performance metrics like sensitivity or specificity for an AI algorithm.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a physical medical device (dental abutment) and not an AI algorithm, the "acceptance criteria" are related to demonstrating that the device performs as safely and effectively as a legally marketed predicate device. The performance is assessed through non-clinical testing against established standards.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Non-clinical Testing) |
|---|---|
| Biocompatibility | The subject device is manufactured using identical methods, facility, and raw material as the predicate (K191152). Patient contact duration and type are the same. IPS e.max® and VITA ENAMIC® (IS) mesostructure materials are cleared under K191382 and K153645 respectively, and no modifications to these materials are included. No new biocompatibility testing was required. |
| Fatigue Testing (Mechanical Performance) | Withstand 2,000,000 cycles without failure at a substantially equivalent load to the cited predicates, as per ISO 14801:2016. Worst-case abutments (narrowest, 20° mesostructure, various materials) were tested. |
| Sterilization Testing | Validated steam sterilization parameters (gravity displacement and pre-vacuum) for inCoris ZI mesostructure according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009. For IPS e.max and VITA ENAMIC (IS) mesostructures, recommended parameters are based on predicate clearances K191382 and K153645. |
| Software Verification and Validation (CAD/CAM Integration) | Software verification and validation testing for the abutment design library demonstrated that restrictions prevent design of the mesostructure component outside of design limitations. The encrypted design library was validated to ensure established limitations are locked and cannot be modified. (For CEREC SW version 4.6.1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of clinical data for AI. For the non-clinical fatigue testing, "worst case abutments" were chosen. The exact number of samples tested for each worst-case configuration (e.g., number of narrowest abutments, number of specific mesostructures) is not explicitly stated but implied to be sufficient for ISO 14801:2016 compliance.
- Data Provenance: Not applicable in the context of clinical or retrospective data for an AI algorithm. The performance data comes from laboratory non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as this is a non-clinical device submission for a physical component, not an AI algorithm requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- Not applicable for a non-clinical device submission.
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
- Not applicable. This is not an AI-assisted diagnostic 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. The software mentioned (CEREC SW version 4.6.1) is for design and milling, not a standalone AI diagnostic algorithm.
7. The Type of Ground Truth Used
- For fatigue testing, the "ground truth" is defined by the mechanical strength and durability requirements of the ISO 14801:2016 standard, ensuring the device can withstand chewing forces.
- For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and prior clearances of materials used.
- For sterilization, the "ground truth" is effective sterilization as demonstrated by ANSI/AAMI/ISO 17665 standards.
- For software verification, the "ground truth" is the established design limitations and the software's ability to enforce them.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI algorithm that requires a training set. The software mentioned (CEREC SW) is a CAD/CAM design software, not a machine learning model developed with a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no training set for an AI algorithm.
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