ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.

Device Description

ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.

AI/ML Overview

The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Product Standard BS EN ISO 6872:2015)	Criteria	Reported Performance (ArgenZ Liquids)
Flexural Strength
ArgenZ HT+	>= 800 MPa	1230 MPa
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)	>= 800 MPa	1223 MPa
ArgenZ Anterior	>= 500 MPa	868 MPa
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3)	>= 500 MPa	765 MPa
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4)	>= 500 MPa	963 MPa
Chemical Solubility
ArgenZ HT+	< 100 ug/cm²	4.16 ug/cm²
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)	< 100 ug/cm²	4.16 ug/cm²
ArgenZ Anterior	< 100 ug/cm²	20.80 ug/cm²
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3)	< 100 ug/cm²	10.32 ug/cm²
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4)	< 100 ug/cm²	8.30 ug/cm²
Cytotoxicity (ISO 10993-5)	Reactivity grade <= 2 (mild reactivity)	All test articles showed no evidence of cell lysis or toxicity (i.e. grade <= 2).

2. Sample Size for Test Set and Data Provenance

Mechanical & Chemical Properties: The document does not specify the exact sample size for each test (flexural strength and chemical solubility). It mentions "test records of parent materials and representative accessories infused into the parent materials," and lists several variations (e.g., ArgenZ HT+, ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.
Cytotoxicity: The document states that "test articles for the cytotoxicity testing were selected as representative samples for each product family, and determined to be worst case scenarios for potential biocompatibility issues." Four specific liquid/zirconia combinations were selected as representative samples (ST on K150919 (A3), ST on K150919 (C4), HT on K071410 (A4), HT on K071410 (B4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.

3. Number of Experts and Qualifications

This document describes a pre-market notification for a dental material, not a diagnostic device involving human interpretation. Therefore, there are no "experts" in the context of establishing ground truth for diagnostic accuracy, nor qualifications for such experts. The evaluation relies on standardized material testing.

4. Adjudication Method

Not applicable, as this is related to material properties testing, not human interpretation of diagnostic results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a dental coloring liquid used by trained dental technicians, not a diagnostic tool where human readers assess cases. The study focuses on material properties, not reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a material, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on product standards (BS EN ISO 6872:2015 for mechanical and chemical properties, and ISO 10993-5 for cytotoxicity). These standards define the acceptable limits for various material properties.

8. Sample Size for Training Set

Not applicable. This is a material, not a machine learning model, so there is no training set in the conventional sense. The "training" in manufacturing refers to established processes and quality control.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for an AI/algorithm. For materials, the "ground truth" for manufacturing involves adherence to established specifications, quality control procedures, and compliance with relevant industry standards and regulations.

Summary

{0}------------------------------------------------

Image /page/0/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 and 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.

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

February 8, 2019

Re: K182833

Trade/Device Name: Argen Z Liquids (ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Pontic Reducer, and ArgenZ Color Modifier) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 16, 2018 Received: November 16, 2018

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

{1}------------------------------------------------

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 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.

Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.02.08 10:01:37 -05'00'

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K182833

Device Name

ArgenZ Liquids (ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Pontic Reducer, and ArgenZ Color Modifier)

Indications for Use (Describe)

ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/8 description: This image is a document that appears to be a 510(k) Summary with the number K182833. It indicates that it was submitted by The Argen Corporation, located in San Diego, CA. The contact person is Craig Jolicoeur, and the date prepared is 9/28/2018. The trade names include ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, and ArgenZ Pontic Reducer, with a common name of ArgenZ Liquids, classification name of Porcelain powder for clinical use (21 CFR 872.6660), classification of Class II, and product code of EIH.

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

510(k)Number	Trade Name	Manufacturer
K111257	HEISENBERG DYEING LIQUIDS	3M ESPE AG

Device Description:

Intended Use:

ArgenZ Liguids are intended to be used by trained dental technicians as an accessory for shading ArgenZ frameworks and ArqenZ all-zirconia, monolithic restorations for anterior and posterior dental prosthetics.

Predicate devices: K111257

{5}------------------------------------------------

Performance Data:

The raw materials and manufacturing process used in the fabrication of ArgenZ Liquids are similar to the materials and processes used in the industry to fabricate the predicate device. Section 18 contains test records of parent materials and representative accessories infused into the parent materials. The results demonstrate compliance with the product standard of the parent material.

Performance Data Summary:

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

Product	Flexural strength[MPa] from standardminimum value for	Test Result
	mean
ArgenZ HT+	800	1230
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)	800	1223
ArgenZ Anterior	500	868
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3)	500	765
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4)	500	963

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

Product	Chemical solubility[ug/cm²]	Test Result
ArgenZ HT+	<100	4.16
ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)	<100	4.16
ArgenZ Anterior	<100	20.80
ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3)	<100	10.32
ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4)	<100	8.30

Predicate Device Comparison (Liquid):

	ArgenZ Liquids	HEISENBERG DYEING LIQUIDS
Properties and Information
510(k)	N/A	K111257
Indications for Use	ArgenZ Liquids are intended to beused by trained dental technicians asan accessory for shading ArgenZframeworks and ArgenZ all-zirconia,monolithic restorations for anterior andposterior dental prosthetics.	Liquid ceramic aid for complete orpartial coloring of all zirconiumoxide blanks intended to be usedfor all ceramic dental restorations
Prescription Use	Prescription Only	Prescription Only
Target Population	General, mostly adults	General, mostly adults
Type of Packaging	Liquid container	Liquid container
Method of Manufacturer	Batch, at VITA shade	Batch, at VITA shade
Packaging Volume (mL)	30 and 100	100 and 250
VITA Shade	16	16
Items in Product Line	~ 90	~50
Storage Conditions	2 years @ 25-75°C	3-4 years at 4-10°C
General Physical Form	Liquid	Liquid
Specific Physical Form	Liquid	Liquid

{6}------------------------------------------------

Odor	Characteristic odor	Characteristic odor
Color	Yellow/orange	Yellow/orange
pH	6.5-7.5	6.5-7.5
Boiling Point	100°C	100°C
Specific Gravity	1.0-1.10 g/cm^3	1.00-1.10 g/cm^3
Solubility in Water	100%	100%
Sterility	Non-sterile	Non-sterile

Summary of the biological testing conducted on the device:

The device was evaluated for cytotoxicity based on ISO 10993-5 (Section 8.2) using the Minimal Essential Media (MEM) Elution Test. According to the criteria described in Table 1 (Section 8.5), a reactivity grade of greater than 2 (mild reactivity) is considered a cytotoxic effect.

Test Requirements & Rationale for Cytotoxicity

Test articles for the cytotoxicity testing were selected as representative samples for each product family, and determined to be worst case scenarios for potential biocompatibility issues. Specified zirconia materials will be used as a medium for testing the products.

Table 1, shows the rationale used to determine which sample set would represent the entire product category. Since direct testing using the overlay method will be employed to determine cytotoxicity of the samples, indirect testing will not be necessary.

Liquids	Shade	Elements Present	Rationale
Type
ST onK150919	A3	Er Fe Ni	Highest Er
ST onK150919	C4	Mn Fe Ni	Mn presence, highestpresence of Ni
HT onK071410	A4	Cr Fe	Highest concentrationof elements
HT onK071410	B4	Pr Fe Cr	Pr presence, Crpresence

Table 1: Rationale for liquid sample selection

All tests articles showed no evidence of causing any cell lysis or toxicity. All test articles met the requirements of the test since the grade was less than or equal to grade 2 (mild reactivity).

Complete test reports are available in Section 15 of this submission.

Conclusion: Due to the lack of response, the products are considered biocompatible and substantially equivalent to the predicate devices.

In addition, strong evidence supporting biocompatibility of the material can be seen when comparing chemical solubility results from the white and shaded materials.

{7}------------------------------------------------

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 the ArgenZ Liquids 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.