(127 days)
Prettau®, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Prettau® 3, Prettau® 3 Coloured, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettaw® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products have been developed for use with Colour Liquid, ICE Zirkon Stains and ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
The subject devices are composed of yttria-stabilized zirconia. They are available in different models that differ in form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
This document describes the premarket notification for PRETTAU®, ICE, and Z-WHITE zirconia blanks. It is not an AI/ML device, therefore the typical acceptance criteria and study data for such devices will not be present.
Here's a breakdown of the relevant information from the document, focusing on the "acceptance criteria" through the lens of a non-AI/ML medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (zirconia blanks for dental restorations), "acceptance criteria" are typically defined by recognized international standards for material properties, rather than performance metrics like sensitivity or specificity.
| Acceptance Criteria (Standard) | Reported Device Performance (PRETTAU®, ICE, and Z-WHITE) |
|---|---|
| ISO 6872:2015 "Dentistry - Ceramic materials" (General requirements for Class 4 & Class 5) | All samples fulfill the requirements of the standard for their respective classes. |
| ISO 10993-1 "Biological Evaluation of Medical Devices" Part 1: Evaluation and Testing (Biocompatibility) | Biocompatibility testing demonstrated no issue of biocompatibility arises. |
| Flexural Strength (for Class 4 materials: min 500 MPa) | Prettau® 3, Prettau® 4 Anterior: 600 MPa |
| Flexural Strength (for Class 5 materials: min 800 MPa) | Prettau®, Prettau® 2, ICE group, Z-White: ≥ 900 MPa |
Study Proving Device Meets Acceptance Criteria:
The document states: "Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 6872 'Dentistry - Polymer-based crown and bridge materials', the devices were tested. All samples fulfil the requirements of the standard." It also mentions biocompatibility testing according to ISO 10993-1.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of samples used for physical or biocompatibility testing. It generally refers to "all samples" fulfilling the requirements, which implies a sufficient number were tested to demonstrate compliance.
- Data Provenance: The testing was "non clinical testing," implying laboratory-based studies conducted by the manufacturer (Zirkonzahn srl. or an accredited lab on their behalf). The country of origin of the data is not explicitly stated but would presumably be related to where Zirkonzahn srl. is based (Italy) or where their testing facilities are located. The data is retrospective in the sense that it was collected prior to this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable to this type of device. The "ground truth" for material properties is established by adherence to published industrial and international standards (like ISO 6872) and objective physical and chemical testing methodologies, not by expert consensus or interpretations of images/data.
4. Adjudication Method
This concept is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., by radiologists or pathologists) to resolve discrepancies. Material property testing relies on objective measurements and established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, typically for diagnostic or screening devices. This device is a material for dental restorations.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the device is not an algorithm or AI system. It is a physical material (zirconia blanks).
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on established international standards (ISO series) for material properties (e.g., flexural strength, chemical composition, biocompatibility). These standards provide quantifiable criteria that the device must meet through objective physical and chemical testing.
8. Sample Size for the Training Set
This is not applicable as the device does not involve an AI/ML algorithm that requires a training set. The device is a manufactured material.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no AI/ML training set.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.