ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

Device Description

ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental ceramic device, ArgenZ Esthetic Plus, and its claim of substantial equivalence to a predicate device, BruxZir Anterior (K143330). The information does not describe a study involving an AI device and human readers, but rather a comparison of physical and biological properties of two ceramic materials.

Therefore, the following points address the questions based on the provided document, acknowledging that most questions related to AI studies are not applicable.

1. Table of acceptance criteria and the reported device performance

Criteria Category	Acceptance Criteria (Predicate)	Reported Device Performance (ArgenZ Esthetic Plus)
Classification of Ceramic	Type II, Class 6 (per ISO 6872)	Type II, Class 5 (The document states "ArgenZ Esthetic Plus satisfies requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008" and then in the comparison table, "Same" next to the predicate's "Type II, Class 6". This appears to be a slight inconsistency in the document's reporting between the general description and the comparison table. For the purpose of this table, I'll use what is explicitly stated for the proposed device's performance, which is Class 5 (and then "Same" for the "Type II"). The comparison table also later confirms "Same" for Classification of Ceramic.)
Material	Tosoh Powder (Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder)	Same (Tosoh Powder; Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder)
Flexural Strength	Meets requirements, per ISO 6872 (>600 MPa Mean Value)	>600 MPa Mean Value
Coefficient of Thermal Expansion (CTE) / (25-500 °C)	11 X 10-6/K	Same (11 X 10-6/K)
Density	6.05 g/cm3	Same (6.05 g/cm3)
Biocompatibility	Biocompatible	Same (Biocompatible, as material is identical)
Intended Use	Fabrication of custom-made all ceramic restorations for anterior and posterior location.	Fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems. (The document states the proposed device has "comparable technical characteristics and Indications for Use to the predicate device" and that "both have the same intended use.")
Product Composition	Pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.	Identical composition
Physical Properties	Satisfy requirements for a Class 6 (Type II) ceramic when tested in accordance with ISO 6872:2008.	Satisfy requirements for a Class 5 (Type II) ceramic when tested in accordance with ISO 6872:2008. (The document states "The materials are identical to the predicate device and hence have the same physical properties." and that it "satisfies requirements for a Class 5 (type II) ceramic when tested in accordance with ISO 6872:2008.")
Safety and Effectiveness	Deemed safe and effective by predicate clearance.	Substantially equivalent in safety and effectiveness to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes material testing for dental ceramics, not a clinical study involving a test set of data. The testing was conducted on samples of the ArgenZ Esthetic Plus material to ensure it meets ISO standards and is comparable to the predicate device. Details on the number of samples or the country of origin for these material tests are not provided. The tests would be prospective in the sense that they are performed on the manufactured material to evaluate its properties.

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 question is not applicable to the provided document. The ground truth for this device relates to the physical and biological properties of the ceramic material, which are established through standardized laboratory testing (e.g., ISO 6872:2008) rather than expert consensus on a test set of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews of data, which is not the nature of the information presented here.

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 question is not applicable. The document describes a medical device in the dental ceramic category, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for the ArgenZ Esthetic Plus device and its predicate is based on standardized laboratory testing and material specifications as defined by ISO 6872:2008 for dental ceramics, as well as the known properties of the base material (Yttrium-stabilized Zirconia) in medical applications. This includes measurements of flexural strength, density, coefficient of thermal expansion, and confirmation of biocompatibility.

8. The sample size for the training set

This question is not applicable. As the document concerns a physical material, there is no "training set" in the context of an AI model. The material's properties are inherent to its composition and manufacturing process.

9. How the ground truth for the training set was established

This question is not applicable. There is no training set for an AI model. The "ground truth" for the material's properties is established through adherence to international standards for dental ceramics (ISO 6872:2008) and well-documented scientific principles of material science and biocompatibility.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2015

The Argen Corporation Mr. Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, CA 92121-4718

Re: K150919

Trade/Device Name: ArgenZ Esthetic Plus Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: March 27, 2015 Received: April 17, 2015

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration. Isting 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. lina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K150919

Device Name: ArgenZ Esthetic Plus

Indications For Use: ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for The Argen Corporation. The logo features a stylized letter "A" with the word "ARGEN" in bold letters. Below the logo is the company name, address (5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America), telephone number (858-455-7900), and fax number (858-626-8686).

510(k) Summary

Submitted by:	The Argen Corporation5855 Oberlin Drive, San Diego, CA 92121(858) 455-7900 x471 (PHONE), (858) 626-8686 (FAX)
Contact person:	Craig Jolicoeur
Date prepared:	3/27/2015
Trade name:Common name:Classification name:Classification:Product Code:	ArgenZ Esthetic PlusDental CeramicPorcelain powder for clinical use (21 CFR 872.6660)Class IIFIH

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

510(k)Number	Trade Name	Manufacturer
K143330	BruxZir Anterior	PRISMATIK DENTALCRAFT, INC.

Device Description:

ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

ArgenZ Esthetic Plus satisfies requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.

Intended Use:

ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.

Predicate device: K143330

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Summary of the physical testing conducted on the device:

The materials are identical to the predicate device and hence have the same physical properties. The properties satisfy requirements for a Class 5 (type II) ceramic when tested in accordance with ISO 6872:2008. A comparison to the predicate device is below:

	Predicate Devices	Proposed Device
	BruxZirTM Anterior (K143330)	Argen Z Esthetic Plus
Classification of Ceramic	Type II, Class 6	Same
Shapes/Sizes	Standard, R, Z, Type, DD, ZZ, ZZ Notch	100/98/95mm Dia x10/14/18/22/25mm High
Material	Tosoh Powder	Same
Flexural Strength	Meets requirements, per ISO 6872	>600 MPa Mean Value
Coefficient of ThermalExpansion (CTE) /(25-500 °C)	11 X 10-6/K	Same
Density	6.05 g/cm3	Same
Biocompatibility	Biocompatible	Same
Indications for Use	The device is indicated for use by dentaltechnicians in the construction of custommade all ceramic restorations for anteriorand posterior location.	ArgenZ Esthetic Plus blanks areintended to be used in thefabrication of inlays, crowns,copings, and fixed bridges (upto 3 units) using variousCAD/CAM systems.

	Comparison between Predicate and Proposed Device

We can conclude that ArgenZ Esthetic Plus have comparable technical characteristics and Indications for Use to the predicate device.

Summary of the non-clinical testing:

Non-clinical test data was used to support the claim of substantial equivalency. The flexural strength, fracture toughness, hardness, and translucency ensure conformance of ArgenZ Esthetic Plus to the input requirements and the flexural strength requirements of ISO 6872:2008.

Conclusion from the non-clinical testing:

The proposed device, ArgenZ Esthetic Plus, is the same material as the predicate device. It has the same performance specifications and intended use as the predicate device - BruxZir Anterior (K143330). There are no changes to the device, so no additional risks are present to the safety and efficacy.

Since the device is made from the same material, and has the same intended use as the predicate device. A conclusion can be drawn that the proposed device is substantially equivalent to the predicate device.

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Summary of the biological testing conducted on the device:

The materials (Yttrium-stabilized Zirconia) used to produce ArgenZ Esthetic Plus have been studied extensively in medical applications. This type of material is the standard used for most all ceramic dental restorations in the world.

Since the material used to produce the blanks is identical to the material used to produce the predicate device (see table on previous page), it follows that the proposed product is biocompatible.

Substantial equivalence/Conclusion:

The proposed and predicate device is composed of a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.

Both the proposed and predicate devices have identical compositions. Also, the physical and biological properties of the predicate and proposed devices are the same. In addition, both have the same intended use. ArgenZ Esthetic Plus is substantially equivalent in safety and effectiveness to the predicate device.

We are claiming substantial equivalence of the ArgenZ Esthetic Plus to the predicate device.

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.