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Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.
Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.
It is prepared for machining by use of CAM-techniques.
The machined frameworks like dental crown and bridge works are sintered to full density.
Nacera Z is a ceramic material for dental restorations.
Nacera Z is composed of partially sintered yttrium oxide stabilized zirconium oxide.
Nacera Z is designed for manufacturing all-ceramic dental restorations (substructures) for the sole use of particular patients. It is machined on milling centers by use of CAD/CAM techniques for design and processing.
Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.
Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.
Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.
All above mentioned advantages ensure safe, resistant, and effective dental restorations.
Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.
Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.
The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.
Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.
Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³
The provided text describes a premarket notification 510(k) for a dental ceramic material called Nacera Z and Nacera Z Medium. This document is a regulatory submission for a medical device and, as such, does not contain information about acceptance criteria or a study proving performance against those criteria in the way envisioned by the request (e.g., clinical study with statistical outcomes).
The document focuses on establishing substantial equivalence to a legally marketed predicate device (Zerion beta) and demonstrating compliance with relevant international standards for dental ceramics and implants.
Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present.
Acceptance Criteria and Device Performance (Based on Regulatory Standards):
| Acceptance Criteria (from International Standards) | Reported Device Performance |
|---|---|
| Meets "Dental ceramic" standard ISO 6872:1999 | Nacera Z meets all applicable requirements of ISO 6872:1999 |
| Meets "Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirkonia" standard ISO 13356:1997 for biocompatible and biostable dental implants and restorations | Nacera Z meets the international standard 13356:1997 |
| Biocompatible | Nacera Z is biocompatible |
| Biostable | Nacera Z is biostable |
| Insoluble in water | Nacera Z is insoluble in water |
| Outstanding high strength of densely sintered ceramic restorations | Due to the outstanding high strength of densely sintered ceramic restorations, Nacera Z enables finely shaped, precise, and filigree framework |
| Enables design of finely shaped, precise, and filigree framework | Enables design of finely shaped, precise, and filigree framework |
| Provides outstanding basis for aesthetical restorations (hue characteristics) | Changes during final sintering to characteristic hues from white to light pearl, offering an outstanding basis for aesthetical restorations |
| Safe, resistant, and effective dental restorations | All mentioned advantages ensure safe, resistant, and effective dental restorations |
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not described in the regulatory summary. The "study" here refers to compliance with international standards, which would involve material testing, not human-subject testing or image-based diagnostic evaluation.
- 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, as this is a material science device, not a diagnostic device requiring expert interpretation of images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a material science device.
- 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, as this is a dental ceramic, not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental ceramic and not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For material properties, the "ground truth" would be established through laboratory testing against the specifications defined by the ISO standards.
- The sample size for the training set: Not applicable, as this is a material science device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as this is a material science device, not a machine learning model.
Summary of what the document does provide:
The document is a 510(k) summary for a dental ceramic material called Nacera Z. It states that the device is designed for dental restorations (single tooth crowns or bridgeworks) and is biocompatible, biostable, and insoluble in water. The key "proof" of meeting acceptance criteria comes from its stated compliance with two international standards:
- ISO 6872:1999 "Dental ceramic": Nacera Z "meets all applicable requirements" of this standard.
- ISO 13356:1997 "Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirkonia": Nacera Z "meets" this standard for biocompatible and biostable dental implants and restorations.
The "study" or evidence of performance is implicitly based on laboratory testing that demonstrates the material's properties (strength, stability, biocompatibility, etc.) conform to the specifications and tests outlined in these ISO standards. The submission relies on this compliance, along with substantial equivalence to a predicate device (Zerion beta, K061804), for regulatory clearance. It does not involve clinical trials or human reader studies.
§ 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.