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510(k) Data Aggregation
(251 days)
Sirona Dental CAD/CAM System with CEREC Chairside Software
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and 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. The system consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two- piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows in the document)
The Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:
- CEREC SW "chairside" CAD/CAM software
- CEREC AC digital acquisition unit
- CEREC AC Connect digital acquisition unit
- CEREC Omnicam 3D digital intraoral scanner
- CEREC MCXL product family of CAM milling units
- Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
- inCoris ZI zirconium mesostructure blocks
As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.
As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.
The CEREC SW CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.
Here's a breakdown of the acceptance criteria and the study information for the Sirona Dental CAD/CAM System with CEREC Chairside Software, based on the provided text:
Preamble: This 510(k) submission, K193408, is for a modification to an existing device (Sirona Dental CAD/CAM System, K181520), specifically a line extension for additional TiBase variants to facilitate compatibility with more dental implant systems. Therefore, the "study" described is primarily focused on demonstrating that the new variants perform comparably to the previously cleared predicate, rather than a de novo clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Geometric compatibility of implant to TiBase connection interface | Confirmed for new Sirona TiBase components via direct access to original manufacturer's implant geometry specifications for Dentsply Sirona, OsseoSpeed TX implant system. Designed through direct reference to original implant design specifications. |
| Dynamic fatigue testing per ISO 14801 (Dentistry - Implants) | Conducted using new TiBase variants in worst-case construct (maximum allowable abutment angulation and worst-case implant connection interface geometry). Results are not explicitly stated as passing a specific threshold in the provided text, but the conclusion states "The results of the performance testing support substantial equivalence." |
| Biocompatibility of new TiBase variants | Composed of identical materials and fabricated using the same methods as components cleared under K181520. No new biocompatibility data included, relying on previous clearance. |
| Steam sterilization parameters for new TiBase components | Identical to validated parameters recommended for TiBase components in K181520. Validation conducted according to ISO 17665-1 and ANSI/AAMI ST79. Reference to original validation supports substantial equivalence. |
| Software system integration testing for TiBase line extension | Conducted to validate system requirements for the introduction of the TiBase component line extension as selectable within CEREC Chairside CAD/CAM software. No modification to critical abutment design parameters. Results are not explicitly stated, but the conclusion states "The results of the performance testing support substantial equivalence." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a specific number for each test. The dynamic fatigue testing mentions "test sample constructs," implying multiple items were tested, but a precise number is not provided.
- Data Provenance: This is non-clinical performance data. The location of the testing is not specified, but it would have been generated by Dentsply Sirona or a contracted testing lab. It is inherently prospective data, generated specifically for this submission to demonstrate the performance of the new TiBase variants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This submission is for a medical device (dental CAD/CAM system components), not an AI/imaging diagnostic device that requires expert review for ground truth establishment. The "ground truth" here is based on engineering specifications, material properties, and standardized performance tests (e.g., ISO 14801).
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical performance testing of physical components and software functionality, there is no expert adjudication process involved in the same way as for diagnostic AI outcomes. The performance is assessed against established engineering standards and design specifications.
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. An MRMC comparative effectiveness study was not performed. This device is a CAD/CAM system for fabricating dental abutments, not an AI diagnostic tool used by human readers to interpret medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, indirectly. The performance tests described (geometric compatibility, dynamic fatigue, biocompatibility, sterilization validation, software integration) evaluate the device's performance in a standalone manner, separate from its use by a human operator in a clinical setting for diagnosis. The software component, specifically, underwent system integration testing to validate its requirements and functionality for designing the mesostructure, which is a standalone algorithm function.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Results:
- Geometric compatibility: Original manufacturer's implant geometry specifications.
- Dynamic fatigue: Adherence to ISO 14801 standards for dental implants.
- Biocompatibility: Previous clearance (K181520) and established material properties.
- Sterilization: Adherence to ISO 17665-1 and ANSI/AAMI ST79 standards.
- Software integration: System requirements and design controls.
8. The Sample Size for the Training Set
- Not Applicable (or not provided in the document). This device is a CAD/CAM system modification, not an AI model that requires a training set in the typical machine learning sense. The software component is likely developed using traditional software engineering principles and validated through integration testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point #8.
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