ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

AI/ML Overview

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from BS EN ISO 6872:2015 via predicate device or standard)	Reported Device Performance (ArgenZ HT+)
Flexural strength: ≥ 800 MPa	1348 MPa (ArgenZ HT+ unshaded)
	1172 MPa (ArgenZ HT+ Shade A4)
	1143 MPa (ArgenZ HT+ Shade OM1)
Chemical solubility: < 100 µg/cm²	66.11 µg/cm² (ArgenZ HT+ unshaded)
	3.10 µg/cm² (ArgenZ HT+ Shade A4)
	3.10 µg/cm² (ArgenZ HT+ Shade OM1)
Coefficient of Thermal Expansion: (Not explicitly stated as a pass/fail criterion, but a comparative value)	10.3 µm/m-C° (25-500°C)
Cytotoxicity: No evidence of cell lysis or toxicity	Met the requirements of the test.

Sample Size and Data Provenance
- The document does not explicitly state the sample size used for the mechanical and chemical property tests. The results are presented as single values (e.g., "Test Result").
- The data provenance is not specified in terms of country of origin or whether the studies were retrospective or prospective. It implies the performance testing was conducted by or for The Argen Corporation as part of their 510(k) submission.
Number of Experts and Qualifications
- This submission is for a dental material (zirconia), not an AI/software device that requires expert review for ground truth. Therefore, there were no experts establishing ground truth in the context of human interpretation of data. The ground truth for material properties is established by standardized laboratory testing methods.
Adjudication Method
- Not applicable for this type of device (dental material). Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation or AI model output where consensus among experts is needed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret images, and the AI assists in this interpretation. This submission is for a dental material with physical and chemical properties.
Standalone (Algorithm Only) Performance
- Not applicable. This is not an algorithm or AI device. The performance data relates to the physical and chemical properties of the zirconia material itself.
Type of Ground Truth Used
- The ground truth for the device's performance relies on objective laboratory measurements based on established international standards (BS EN ISO 6872:2015 for mechanical/chemical properties and ISO 10993-5 for biocompatibility/cytotoxicity). This is akin to "outcomes data" in a broader sense of directly measured physical properties and biological responses, rather than expert consensus on subjective interpretations.
Sample Size for the Training Set
- Not applicable. This is a material, not a machine learning model, so there is no concept of a "training set" in this context.
How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a material. The "ground truth" for the material's properties is established through the standardized testing methodologies detailed above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "The Argen Corporation". The logo includes the text "Alloy Makers To The World" and the company name "ARGEN" in a bold font. The image also includes the company's address, which is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America, as well as their telephone and fax numbers: (858) 455-7900 and (858) 626-8686, respectively.

510(k) Summary K190079

Submitted by:	The Argen Corporation5855 Oberlin Drive, San Diego, CA 92121(858) 455-7900 x471 (Phone), (858) 626-8655 (FAX)
Contact person:	Craig Jolicoeur
Date prepared:	3/26/2019
Trade name:Common name:Classification name:Classification:Product Code:	ArgenZ HT+ArgenZPorcelain powder for clinical use (21 CFR 872.6660)Class IIEIH

Legally marketed devices for which our organization is claiming substantial equivalence:

510(k)Number	Trade Name	Manufacturer
K180252	PrimaryPredicateDevice	Crown Dental Zirconia Blank& Crown Dental Zirconia Pre-Shaded Blank	Crown Porcelain Dental TechnologyCo., Ltd.
K071410	ReferenceDevice	Argen Pearl Brand Zirconia	The Argen Corporation

Device Description:

ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

Intended Use:

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructure restorations up to a full arch.

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Performance Data:

The raw materials and manufacturing process used in the fabrication of ArgenZ HT+ are similar to the materials and processes used in the industry to fabricate the predicate devices. Both materials fall into the same product classification (Class 5) per ISO 6872. Both have stated similar intended uses, chemical compositions, and physical properties. The results demonstrate compliance with the product standard and support our claim for substantial equivalence.

Performance Data Summary:

Summary of mechanical properties of proposed device to the product standard (BS EN ISO 6872:2015).

Product	Flexural strength[MPa] from standardminimum value formean	Test Result	Product	Coefficient of ThermalExpansion	Test Resultum/m-C°
ArgenZ HT+	800	1348	ArgenZ HT+	25-500°C	10.3
ArgenZ HT+ Shade (A4)	800	1172	Argen Pearl Brand Zirconia	0-800°C	9
ArgenZ HT+ Shade (OM1)	800	1143
Argen Pearl Brand Zirconia	800	900

Summary of chemical properties of the proposed device to the product standard (BS EN ISO 6872:2015)

Product	Chemical solubility[µg/cm²]	Test Result
ArgenZ HT+	<100	66.11
ArgenZ HT+ Shade (A4)	<100	3.10
ArgenZ HT+ Shade (OM1)	<100	3.10

Predicate Device Comparison:

ITEM	Subject DeviceArgenZ HT+	Predicate DeviceK180252
Product Code	EIH	EIH
RegulationNumber	872.6660	872.6660
Intended Use	ArgenZ HT+ (high translucentplus) zirconia can be used for theproduction of full contour andsubstructure restorations up to afull arch.Note: The predicate device statesan intended use that is specific tothe manufactures business.Both materials can be used for theapplications stated by thepredicate.Both meet Class 5 mechanical andchemical property requirements ofISO 6872.We recommend theaforementioned Intended use.	Crown Dental Zirconia Blank & CrownDental Zirconia Pre-Shaded Blank areindicated for the production of artificialteeth in fixed or removable dentures,or for jacket crowns, facings, andveneers.
Feature	Shaded	Colored
Shape	Discs	Discs
Type and Class perISO 6872:2015	Type II Class 5	Type II Class 5
Sterility	Non-sterile	Non-sterile
ChemicalComposition(Weight %)	ZrO2+HfO2+Y2O3 > 99 wt%Inorganic Pigments < 1%	ZrO2>99.0%Inorganic Pigment(Al2O3, SiO2, Fe2O3, Er2O3) < 1%
CrystalMorphology	Tetragonal	Tetragonal
Density	6.08g/cm3	6.00g/cm3
Sinteringtemperature	1500°C	1500±50°C
Performance	Comply with ISO 6872	Comply with ISO 6872
Contact Level	surface device with permanentcontact (>30 days)	surface device with permanent contact(>30 days)
Biocompatibility	Tested for Cytotoxicity on shadedmaterial, no adverse reactionsidentified.	Tested for Cytotoxicity, irritation,sensitization, accurate systematictoxicity, genotoxicity, no adverse reactidentified.

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Summary of the biological testing conducted on the device:

The device was evaluated for cytotoxicity based on ISO 10993-5 using the ISO Agarose Overlay Method.

Test Results/Summary:

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The test article showed no evidence of causing cell lysis or toxicity. The test article met the requirements of the test.

Conclusion:

The proposed and predicate devices are composed of a similar material makeup. All devices have similar indications for use.

The proposed and predicate devices have similar properties.

The performance results and technical characteristics support the findings of substantial equivalence.

We are claiming substantial equivalence of ArgenZ HT+ to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for "The Argen Corporation". The logo includes the company name, address, phone number, and fax number. The address is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The phone number is (858) 455-7900 and the fax number is (858) 626-8686.

Indications for Use Statement

Device Name: ArgenZ HT+

Indications for Use:

ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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Image /page/5/Picture/0 description: The image contains 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.

April 12, 2019

The Argen Corporation Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, California 92121

Re: K190079

Trade/Device Name: ArgenZ HT+ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2018 Received: January 16, 2019

Dear Craig Jolicoeur:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 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.