(101 days)
ZERION is a dental ceramic designed for the fabrication of dental restorations by dental technicians. ZERION delivery state is a yttria (yttrium oxide) – stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density. ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications: on both anterior and posterior locations.
ZERION is a dental ceramic being composed of partially sintered yttrum oxide stabilized zirconium oxide. ZERION is designed for manufacturing of all-ceramic dental restorations like crown, bridgework, and related dental appliances to be machined on milling centers using CAD/CAM techniques for design and processing. ZERION is designed for use as dental restorations like single tooth crowns or bridgeworks with up to two pontics for the anterior and posterior teeth regions equally. The restorations made-up of ZERION are destinated for the sole use of particular patients. ZERION is biocompatible and insoluble in water. Due to the outstanding high strength of densely sintered ceramic Zerion restorations enable dental technicians to design finely shaped, precise, and filigree framework. The characteristic white color offers an outstanding basis for aesthetical restorations. All these advantares together ensure safe, resistant, and effective dental restorations. ZERION substructures are well suited to be veneered with suitable dental porcelains using the layering technique. ZERION meets all applicable requirements for biocompatible dental restorations of the international standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirkonia". The partially sintered ZERION blanks are fabricated in two different types distincted by their presintered density and each type available as disks with different dimensions as follows: ZERION alpha, ZERION beta.
The provided text describes the ZERION dental ceramic device and its premarket notification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.
Instead, the document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device (XAWEX G 00, 510(k) number K050903) and meeting applicable international standards for dental ceramics.
Here's what can be extracted from the provided text, and what is explicitly missing based on your request:
Information Present in the Text:
- Device Description: ZERION is a dental ceramic composed of partially sintered yttrium oxide stabilized zirconium oxide, designed for manufacturing all-ceramic dental restorations (crowns, bridgework) using CAD/CAM techniques. It's intended for single-tooth crowns or bridgeworks with up to two pontics for anterior and posterior teeth.
- Biocompatibility and Standards Met: ZERION is biocompatible, insoluble in water, and meets applicable requirements for biocompatible dental restorations of ISO 6872:1999 "Dental ceramic" and ISO 1335:1997 "Implants for surgery – Ceramic materials based on Yttria-stabilized tetragonal zirconia". These standards likely contain performance specifications relevant to material properties, but specific acceptance criteria for diagnostic performance (as implied by your request related to AI/ML and human readers) are not detailed.
- Regulatory Classification: Class II, Product Code EIH, Regulation Number 872.6660 (Porcelain Powder for clinical use).
- Indications for Use: Fabrication of dental restorations (framework/substructure) for single tooth or bridge type applications on both anterior and posterior locations by dental technicians, using CAD/CAM techniques.
Information NOT Present in the Text (and therefore cannot be provided for your specific questions):
- A table of acceptance criteria and the reported device performance (in the context of diagnostic/AI performance). The document mentions meeting ISO standards but doesn't list specific performance metrics like sensitivity, specificity, or image quality assessments related to AI.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion:
The provided document describes a dental material (ceramic for restorations), not a diagnostic device involving AI/ML or human interpretation of medical images. Therefore, the questions related to diagnostic performance, ground truth, expert adjudication, and AI assistance do not apply to the content of this 510(k) summary. The "acceptance criteria" mentioned are likely related to material properties (strength, biocompatibility, dimensions) as per the ISO standards cited, rather than diagnostic accuracy.
§ 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.