(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.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)