(115 days)
The Perfit ZR HT Dental Zirconia blank are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
The Perfit ZR HT Dental Zirconia blank consists of zirconium oxide which compresses ceramic for milling, grinding, and further firing. It is normally pre-sintered and milled by dental technician with CAD/CAM machine for shaping artificial teeth such as crowns, bridges, veneers, inlay etc.
The Perfit ZR HT Dental Zirconia blank are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
They are available in different models that differ in various specification and color. There are white zirconia products(W) and colored zirconia products, and colored zirconia is also divided into Monolayer(A1, A2, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4) color products and multi-layer(A1 SM, A2 SM, A3.5 SM, A4 SM, B1 SM, B2 SM, B3 SM, B4 SM, C1 SM, C2 SM, C3 SM, C4 SM, D2 SM, D3 SM, D4 SM) color products.
The white zirconia is composed of Zr02+HfO2+Y2O3 and an additional inorganic pigment: Al203 and Other oxide. The color zirconia products are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe203 +Pr203 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
This document is a 510(k) Premarket Notification from the FDA for a dental product, "Perfit ZR HT Dental Zirconia blank." The document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data and does not describe a study involving device performance for diagnostic accuracy or human-in-the-loop AI assistance.
Therefore, many of the requested details, such as acceptance criteria for diagnostic performance, sample sizes for test/training sets with data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to the information provided in this document.
The document describes material and performance requirements for the dental zirconia blank itself, rather than a diagnostic device that performs a "study" in the typical sense of evaluating an algorithm's accuracy.
Here's a breakdown of what can be extracted from the provided text, and where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are based on meeting established international standards for dental ceramic materials and biocompatibility. The reported device performance is that it met these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Conclusion) |
|---|---|
| ISO 6872:2015 - Dentistry: Ceramic Materials (Classification: Type II, Class 5) | "The performance of formed zirconia dental blanks meets the applicable requirements of the following FDA recognized standards: ISO 6872: 2015- Dentistry-Ceramic Materials" |
| ISO 13356:2015, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | "The composition of the Dental Zirconia Blocks including the white zirconia and the color zirconia conforms to ISO 13356:2015... and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials." |
| ISO 10993-1:2018, Biological evaluation of medical devices — Part 5: Evaluation and testing within a risk management process | "Tested to ISO 10993-1" (Implied compliance through testing) |
| ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. | Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard. |
| ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. | Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard. |
| ISO 10993-6 Biological evaluation of the medical devices – Part 6: Tests for Local Effects after Implantation. | Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard. |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation ('Oral mucosa irritation) and skin sensitization. | Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard. |
| ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity | Implied compliance through "Tested to ISO 10993-1" and listed for specific tests within this standard. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to non-clinical bench testing of material properties, not clinical diagnostic performance. The document only mentions "Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015 and ISO 13356: 2015." The tests would involve specific numbers of material samples, but these are not disclosed here.
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)
This information is not applicable as the evaluation is based on meeting material and biocompatibility standards through bench testing, not on human interpretation or diagnostic accuracy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. This document is for a dental material (zirconia blank), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a dental material, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to established international standards for material properties and biocompatibility as determined by standardized laboratory tests. For example, "The composition of the Dental Zirconia Blocks... conforms to ISO 13356:2015" and "Physical and mechanical properties... were evaluated according to ISO 6872:2015."
8. The sample size for the training set
This information is not applicable. This is a dental material subject to non-clinical bench testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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.