(66 days)
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals.
The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia.
They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese.
The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.
The provided document is a 510(k) Premarket Notification for a dental device, ArgenZ MTZ, which is a dental zirconia ceramic. It outlines the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
This document describes the device itself and its physical and chemical properties, but does not describe a study involving a human expert in the loop (e.g., radiologist) or an AI algorithm for diagnostic purposes. Therefore, many of the requested items related to AI/human performance studies are not applicable to the information contained in this document.
However, I can extract information related to the acceptance criteria for the device's physical and chemical properties and how those properties were tested.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a "Substantial Equivalence Comparison Table" that lists various physical and chemical properties and the device's performance against specified criteria, which effectively serve as acceptance criteria to demonstrate equivalence to the predicate device and compliance with ISO standards.
| Acceptance Criteria (Property) | Acceptance Standard / Predicate Performance | Reported Device Performance (ArgenZ MTZ) |
|---|---|---|
| Classification (per ISO 6872:2015) | Class 5 (Predicate) | Class 5 |
| Composition | Yttria-stabilized zirconia (5Y on top of 4Y - Predicate) | Based on yttria-stabilized zirconia, 5Y zirconia on top of 4Y zirconia |
| Color | Color (Predicate) | Color |
| Intended User | Professional dental technicians (Predicate) | Professional dental technicians |
| Single Use | Yes (Predicate) | Yes |
| Sterile | Non-sterile (Predicate) | Non-sterile |
| Physical Properties | Conform to ISO 6872:2015 (Predicate) | Conform to ISO 6872:2015 |
| Uniformity | Uniform (Predicate) | Uniform |
| Freedom from extraneous materials | Free from extraneous materials (Predicate) | Free from extraneous materials |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ (Predicate) | ≤ 1.0 Bq·g⁻¹ |
| Flexural strength | ≥ 800 MPa (Predicate: Multilayer-3Dpro) | ≥ 800 MPa |
| Chemical solubility | < 100 µg/cm² (Predicate) | < 100 µg/cm² |
| Linear thermal expansion coefficient | (10.4±0.5)×10⁻⁶ K⁻¹ (Predicate: Multilayer-3D pro) | (9.9)×10⁻⁶ K⁻¹ |
| Biocompatibility | Conforms to ISO 7405:2018 (Predicate) | Conforms to ISO 10993-1 |
| Labeling | Complies with 21 CFR 801 (Predicate) | Complies with 21 CFR 801 |
2. Sample size used for the test set and the data provenance
The document states, "Bench testing, performed according to ISO 6872:2015 Dentistry – Ceramic materials, showed the ArgenZ MTZ meets the requirements specified in the standard."
While it specifies the standard used for testing, it does not provide the specific sample size (e.g., number of discs or samples tested for each property) nor the data provenance (e.g., country of origin, retrospective/prospective). The testing would have been conducted on a representative sample of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, and the "ground truth" for its performance is established through standardized physical and chemical bench testing, not expert interpretation of outputs like in AI/imaging studies.
4. Adjudication method for the test set
Not applicable. This is not a study involving human readers or AI algorithms requiring adjudication.
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 document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm is being evaluated.
7. The type of ground truth used
The ground truth for the device's performance is established by objective measurements and adherence to recognized international standards for dental ceramic materials, specifically ISO 6872:2015 (for ceramic materials) and ISO 10993-1 (for biocompatibility). This is akin to "bench test results" against specified industry standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured dental material.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2024
Argen Corporation % Patsy Trisler Owner/Regulatory Consultant Trisler Consulting (dba) 306 Turnberry Ct Lebanon, Indiana 46052
Re: K242458
Trade/Device Name: ArgenZ MTZ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 19, 2024 Received: August 19, 2024
Dear Patsy Trisler:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
ArgenZ MTZ
Indications for Use (Describe)
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Number: | K242458 |
|---|---|
| SUBMITTER Name: | The Argen Corporation |
| Address: | 5855 Oberlin DriveSan Diego, CA 92121-3706 |
| Contact Person: | Paul Cascone |
| Phone: | 858.455.7900 |
| Date Prepared: | October 17, 2024 |
| DEVICE TradeName: | ArgenZ MTZ |
| Common Name: | Dental Zirconia Ceramics |
| Classification Name | Porcelain powder for clinical use |
| Number | 21 CFR 872.6660 |
| Product Code | EIH |
| Regulatory Class | 2 |
| Review Panel | Dental |
| PRIMARYPREDICATE: | K222626, Dental Zirconia Ceramic, Aidite (Qinhuangdao)Technology Co., Ltd |
| REFERENCEDEVICES: | K150919, ArgenZ Esthetic Plus, The Argen Corporation |
| K190079, ArgenZ HT+, The Argen Corporation | |
| DEVICEDESCRIPTION | The ArgenZ MTZ (referring to multi-translucent, multi-layer)zirconia consist of yttria-stabilized pre-shaded 4 mole and 5mole percent zirconia. |
| They are manufactured (pressed and sintered) into disc formsand offered multiple thicknesses and multiple shades. Theycontain oxides of Hafnium and Aluminum and minute amountsof coloring oxides of iron, erbium, cobalt and manganese. | |
| The discs are single use, non-sterile devices and used forfabricating dental restorations, using CAD/CAM systems thatcan accommodate the disc sizes. | |
| SUMMARY OFTECHNOLOGICALCHARACTERISTICS | The zirconia material complies with ISO 6872:2015 as a type II,meeting the requirements for a class 5 material, with:• flexural strength above 800 MPa and• chemical solubility of less than 100 µg/cm². |
| The physical device is a disc with thicknesses that vary from 10mm to 30mm. Within a given thickness the top layer is made of5 Y Zirconia, the bottom layer from 4 Y zirconia with theintervening layers different combinations of 5Y and 4Y. | |
| The color intensity increases going from incisal to dentine andthe yttria content decreases from incisal to dentine. | |
| INDICATIONS FORUSE STATEMENT | ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a fullarch.All blanks are processed by dental laboratories or by dentalprofessionals. |
| SAFETY TESTING | The device's biocompatibility was evaluated according to ISO10993, Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk management system. |
| According to the Biological Risk Assessment, Cytotoxicitytesting (per ISO 10993-5:2009) was conducted. | |
| PERFORMANCETESTING | Bench testing, performed according to ISO 6872:2015Dentistry – Ceramic materials, showed the ArgenZ MTZ meetsthe requirements specified in the standard. The testmeasurements are in the SE table below. |
| In vivo Animal and Human Clinical performance testing were notprovided for this submission. | |
| COMPARISON TOTHE PREDICATEDEVICEandSUBSTANTIALEQUIVALENCECONCLUSION | The information and data provided in this 510(k) establish thatthe ArgenZ MTZ zirconia device is substantially equivalent tothe Aidite primary predicate device's Multilayer 3D-pro model inthe intended use, design, principle of operation, and technologyincluding the use of the same zirconia materials. |
| Further ArgenZ MTZ's material is a combination of the tworeference devices, Argen's K150919 (consisting of 5 molepercent zirconium) and K190079 (consisting of 4 mole percentzirconium); and ArgenZ MTZ is manufactured using the sameprocesses. | |
| The differences in the Indications for Use statement betweenArgenZ MTZ and the primary predicate does not change theIntended Use – both are zirconia blanks for use in makingdental restorations with CAD/CAM technologies. | |
| For complete presentation of the similarities and differences,see the following SE Comparison table. |
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Substantial Equivalence Comparison Table
| Comparison item | Proposed Device (K242458) | Predicate Device (K222626) | Comment |
|---|---|---|---|
| Manufacturer | The Argen Corporation | Aidite (Qinhuangdao) TechnologyCo., Ltd. | None |
| Product Name | ArgenZ MTZ | Dental Zirconia Ceramic | None |
| Product Code | EIH | EIH | Same |
| RegulationNumber | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription Use | Yes | Yes | Same |
| Indications forUse | ArgenZ MTZ zirconia can be usedfor the production of full-contourand substructure restorations upto and including a full arch.All blanks are processed bydental laboratories or by dentalprofessionals. | Dental Zirconia Ceramic are usedfor dental restorations usingdifferent CAD/CAM or manualmilling machines.All blanks are processed throughdental laboratories or by dentalprofessionals. | Same IntendedUseSimilarIndications |
| Class (perISO 6872:2015) | Class 5 | Class 5: Multilayer-3D pro | Same |
| Composition | Based on yttria-stabilized zirconia5Y zirconia on top of 4Y zirconia | Based on yttria-stabilized zirconia5Y zirconia on top of 4Y zirconia | Same |
| Color | Color | Color | Similar |
| Intended User | Professional dental technicians | Professional dental technicians | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| PhysicalProperties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom fromextraneousmaterials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ | ≤ 1.0 Bq·g⁻¹ | Same |
| Flexural strength | ≥ 800 MPa | Multilayer-3Dpro: ≥800 MPa | Similar |
| Chemicalsolubility | < 100 µg/cm² | < 100 µg/cm² | Same |
| Linear thermalexpansioncoefficient | (9.9)×10⁻⁶ K⁻¹ | Multilayer-3D pro:(10.4±0.5)×10⁻⁶ K⁻¹ | Similar |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 7405:2018 | Similar |
| Labeling | Complies with 21 CFR 801 | Complies with 21 CFR 801 | Same |
§ 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.