(129 days)
Perfit ZR ST Dental Zirconia blank and Perfit ZR UT 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 ST Dental Zirconia blank and Perfit ZR UT 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 ST Dental Zirconia blank and Perfit ZR UT 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 , Shade multi-layer(A1 SM, A2 SM, A3 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 and Trans&Shade multi-layer(A1 TM, A2 TM, A3 TM, A3 TM, A4 TM, B1 TM, B2 TM, B3 TM, B4 TM, C1 TM, C2 TM, C3 TM, C4 TM, D2 TM, D3 TM, D4 TM) color products.
The white zirconia is composed of ZrO2+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 +Er203. 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.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) summary, the device is Perfit ZR ST Dental Zirconia blank and Perfit ZR UT Dental Zirconia blank, which are dental materials, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, expert adjudication, MRMC studies, and ground truth for algorithms are not applicable to this submission.
The acceptance criteria and supporting studies for this device primarily revolve around material properties and biocompatibility as defined by recognized international standards for dental ceramic materials and medical device biological evaluation.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Standard) | Specific Acceptance Criteria (from standard) | Reported Device Performance |
|---|---|---|
| Physical & Mechanical Properties: | (Implied by adherence to ISO 6872:2015 & ISO 13356:2015 for dental ceramic materials) | "Bench testing was performed per ISO 6872:2015 and ISO 13356:2015 to ensure that the... met its specifications. All tests were verified to meet acceptance criteria." |
| ISO 6872:2015 - Dentistry - Ceramic Materials | Classification: Type II, Class 4 (for monolithic ceramic for specific prostheses) | Device classified as Type II, Class 4. Implicitly meets performance requirements for this classification (e.g., flexural strength, fracture toughness, chemical solubility, etc., although specific values are not explicitly stated in this summary). |
| ISO 13356:2015 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | (Compositional requirements for Y-TZP, e.g., ZrO2+HfO2+Y2O3 content) | "The composition of the Dental Zirconia Blocks... conforms to ISO 13356:2015." |
| Biocompatibility: | (Implied by adherence to ISO 10993 series) | |
| ISO 10993-05: Cytotoxicity | No cytotoxic reactivity | "No cytotoxic reactivity under the condition of the study" |
| ISO 10993-10: Sensitization | Not a sensitizer | "Not a sensitizer under the conditions of the study" |
| ISO 10993-10: Intracutaneous Reactivity | No intracutaneous reactivity | "No intracutaneous reactivity" |
| ISO 10993-11: Systemic Toxicity (Acute) | No systemic toxicity | "No systemic toxicity under the condition of the study" |
| ISO 10993-03: Genotoxicity | No possibility of genotoxicity | "No possibility of genotoxicity under the condition of the study" |
| ISO 10993-6: Local Effects after Implantation | (Implied "meets requirements") | Not explicitly detailed in the table, but mentioned as tested. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each test (e.g., how many specimens were tested for flexural strength, or how many animals for biocompatibility). The summary indicates "A series of tests were conducted on the subject device for the Biocompatibility" and "Bench testing was performed per ISO 6872:2015 and ISO 13356:2015". These standards specify the number of samples required for each particular test.
- Data Provenance: The tests are "bench tests" and "biocompatibility tests." These are laboratory tests conducted on the manufactured material, not clinical data from patients. The location where these specific tests were conducted is not mentioned, but the manufacturer is based in Korea, South. The nature of these tests is usually prospective and controlled, following the protocols outlined in the respective ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a material science and biocompatibility assessment, not a diagnostic or AI performance study that requires expert readers for ground truth establishment. The "ground truth" here is determined by objective measurements against established international standards.
4. Adjudication method for the test set
- Not Applicable. See 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
- Not Applicable. This is not an AI-assisted diagnostic device. No human reader studies were conducted as part of this submission. "Clinical testing was not required for this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- For Physical and Mechanical Properties: The ground truth is defined by the objective performance requirements (e.g., minimum flexural strength, maximum solubility) specified in the relevant ISO standards (ISO 6872:2015 and ISO 13356:2015). Measurements are taken using calibrated laboratory equipment.
- For Biocompatibility: The ground truth is based on the biological responses observed in in vitro (e.g., cytotoxicity) and in vivo (e.g., sensitization, systemic toxicity) tests, as prescribed by the ISO 10993 series of standards. The "truth" is whether the material elicits a biologically acceptable response according to the standard's criteria.
8. The sample size for the training set
- Not Applicable. This device, being a dental material, does not involve machine learning or an AI algorithm, and therefore doesn't have a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not Applicable. See 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.