(273 days)
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. 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 implants systems:
- Nobel Biocare Replace (K020646) .
- Nobel Biocare Branemark (K022562)
- Friadent Xive (K013867) ●
- . Biomet 3i Osseotite (K980549)
- Astra Tech Osseospeed (K091239) ●
- . Zimmer Tapered Screw-Vent (K061410)
- . Straumann SynOcta (K061176)
- Straumann Bone Level (K053088, K062129, K060958) .
- Biomet 3i Certain (K014235, K061629) .
- . Nobel Biocare Active (K071370)
The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises
- Titanium bases TiBase and Camlog .
- . inCoris ZI meso blocks
- Sirona Dental CAD/CAM Design and fabricating devices .
This is a 510(k) premarket notification for a dental device, not a study evaluating performance against acceptance criteria with a test set and ground truth. Therefore, many of the requested elements (acceptance criteria table, sample size, data provenance, expert adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in the provided document.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, indications, construction materials, principles of operation, features, and technical data.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission and not a performance study against specific acceptance criteria, a table directly outlining clinical acceptance criteria and device performance is not provided in this format. The "performance" is implicitly demonstrated through the device's technical specifications aligning with those of the predicate devices and existing standards.
| Component | Acceptance Criteria (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| TiBase | - Material: Ti6Al4V, medical grade 5 (ISO 5832-3:1996) | - Made of Ti6Al4V. |
| - Compatible connection interfaces, anti-rotational features, and screw geometry with specific implant systems. | - Compatibility demonstrated with various Nobel Biocare, Straumann, Astra Tech, Friadent, Biomet 3i, and Zimmer implant systems (as detailed in Table 1, 2, and 5). - Connection interfaces, anti-rotational features, and screw geometry are "identical" or "same" as predicate devices for each corresponding implant system (as detailed in Table 5). | |
| inCoris ZI meso blocks | - Material Composition & Properties: Complies with ISO 13356:1997 for yttria-stabilized tetragonal zirconia (Y-TZP). - Specific physical properties (Density, CTE, Flexural strength, Fracture toughness, Grain Size) meet or exceed specified values. | - Made of zirconium oxide; composition aligns with ISO 13356:1997. - Density: 6.06 g/cm³ - Coefficient of thermal expansion (CTE): 11.0*10⁻⁶ K⁻¹ - Flexural strength: > 900 MPa - Fracture toughness (KIC): 5.9 MPa·m¹/² (K100152 listed 5.8 MPa·m¹/² for predicate) - Grain Size: about 0.5 µm - Bonding Material: Panavia F 2.0 |
| CAD/CAM System (Software) | - Functionality for optical impression, data processing, design, milling data export, patient data administration, calibration, online capabilities, and implant interface scanning, consistent with predicate. | - No modification from predicate (K100152) in core functionalities: optical impressions, CAD/CAM design, milling data export, patient data administration, calibration, online capabilities, scanning implant interface, custom wax-up, meso-structure preparation, bonding milled zirconia/ceramic, and creation of fitting crown (Table 7). - Software database of titanium bases extended to cover new additional titanium bases. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This document does not describe a clinical performance study with a test set. It describes non-clinical testing for material properties and mechanical fatigue.
- Data Provenance: Not applicable for a clinical test set. Nonclinical testing implicitly performed by the manufacturer, Sirona Dental Systems GmbH (Germany).
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)
- Not applicable. There was no clinical test set for which ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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 a dental CAD/CAM system for fabricating restorations, 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 is a CAD/CAM system, which involves human design and fabrication alongside machine processes. "Standalone" performance in the sense of a diagnostic algorithm is not relevant here. The nonclinical testing for the components (TiBase and inCoris ZI meso) and software functionality demonstrate their individual performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Nonclinical Tests: The "ground truth" for the material and mechanical tests would be defined by the relevant ISO standards (e.g., ISO 5832-3:1996 for TiBase, ISO 13356:1997 for inCoris ZI meso blocks) and engineering specifications for fatigue analysis and dimensional accuracy. The software validation followed IEC 62304:2006 for medical device software.
8. The sample size for the training set
- Not applicable. This document describes a new device for which manufacturing and material specifications are compared to predicate devices and standards, not an AI/ML model that requires a training set. The "software database of titanium bases has been extended," which implies data was added, but not in the context of "training data" for a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set for a machine learning model is mentioned.
§ 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.)