Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material composition and manufacturing process of zirconia discs for dental restorations, with no mention of AI or ML technology.

Therapeutic

No.
The device is a material (zirconia disc) used for fabricating dental restorations, not a device that directly provides therapy.

Diagnostic

No
The device is described as zirconia blanks used for fabricating dental restorations, which are used to replace or restore teeth, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (zirconia discs) used for fabricating dental restorations, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the production of dental restorations (full-contour and substructure restorations). This is a mechanical/structural application within the mouth, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The device is a material (zirconia discs) used for fabricating dental restorations. It's a physical component of a dental prosthesis.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
Performance Studies: The performance studies mentioned are bench testing according to a standard for dental ceramic materials, focusing on mechanical properties. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc., which are typical for IVDs.

In summary, the ArgenZ MTZ zirconia is a material used in the fabrication of dental prosthetics, which falls under the category of dental devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device Description

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 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 10 mm to 30mm. Within a given thickness the top layer is made of 5 Y Zirconia, the bottom layer from 4 Y zirconia with the intervening layers different combinations of 5Y and 4Y. The color intensity increases going from incisal to dentine and the yttria content decreases from incisal to dentine.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental laboratories or by dental professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing, performed according to ISO 6872:2015 Dentistry – Ceramic materials, showed the ArgenZ MTZ meets the requirements specified in the standard. The test measurements are in the SE table below.

In vivo Animal and Human Clinical performance testing were not provided for this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural strength: ≥ 800 MPa
Chemical solubility:

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.

Summary

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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

2

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)

K242458

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 Drive
San Diego, CA 92121-3706
Contact Person:	Paul Cascone
Phone:	858.455.7900
Date Prepared:	October 17, 2024
DEVICE Trade
Name:	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
PRIMARY
PREDICATE:	K222626, Dental Zirconia Ceramic, Aidite (Qinhuangdao)
Technology Co., Ltd
REFERENCE
DEVICES:	K150919, ArgenZ Esthetic Plus, The Argen Corporation
	K190079, ArgenZ HT+, The Argen Corporation
DEVICE
DESCRIPTION	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.
SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS	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 10
mm to 30mm. Within a given thickness the top layer is made of
5 Y Zirconia, the bottom layer from 4 Y zirconia with the
intervening layers different combinations of 5Y and 4Y.
	The color intensity increases going from incisal to dentine and
the yttria content decreases from incisal to dentine.
INDICATIONS FOR
USE STATEMENT	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.
SAFETY TESTING	The device's biocompatibility was evaluated according to ISO
10993, Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management system.
	According to the Biological Risk Assessment, Cytotoxicity
testing (per ISO 10993-5:2009) was conducted.
PERFORMANCE
TESTING	Bench testing, performed according to ISO 6872:2015
Dentistry – Ceramic materials, showed the ArgenZ MTZ meets
the requirements specified in the standard. The test
measurements are in the SE table below.
	In vivo Animal and Human Clinical performance testing were not
provided for this submission.
COMPARISON TO
THE PREDICATE
DEVICE
and
SUBSTANTIAL
EQUIVALENCE
CONCLUSION	The information and data provided in this 510(k) establish that
the ArgenZ MTZ zirconia device is substantially equivalent to
the Aidite primary predicate device's Multilayer 3D-pro model in
the intended use, design, principle of operation, and technology
including the use of the same zirconia materials.
	Further ArgenZ MTZ's material is a combination of the two
reference devices, Argen's K150919 (consisting of 5 mole
percent zirconium) and K190079 (consisting of 4 mole percent
zirconium); and ArgenZ MTZ is manufactured using the same
processes.
	The differences in the Indications for Use statement between
ArgenZ MTZ and the primary predicate does not change the
Intended Use – both are zirconia blanks for use in making
dental 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) Technology
Co., Ltd.	None
Product Name	ArgenZ MTZ	Dental Zirconia Ceramic	None
Product Code	EIH	EIH	Same
Regulation
Number	21 CFR § 872.6660	21 CFR § 872.6660	Same
Classification	Class II	Class II	Same
Prescription Use	Yes	Yes	Same
Indications for
Use	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.	Dental Zirconia Ceramic are used
for dental restorations using
different CAD/CAM or manual
milling machines.
All blanks are processed through
dental laboratories or by dental
professionals.	Same Intended
Use
Similar
Indications
Class (per
ISO 6872:

      | Class 5                                                                                                                                                                                                                         | Class 5: Multilayer-3D pro                                                                                                                                                                                      | Same                                           |