DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Device Description

The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 45 shades are available in 15ml, 20ml, 30ml, 40ml and 100ml volumes. We offer the product in four different names: DMAX Coloring Liquid, Chang's Liquid, Confident Coloring Liquid, CAMeleon Coloring Liquid. They are just different names for the same products.

AI/ML Overview

This document describes the premarket notification for DMAX Coloring Liquid and related products. It is not an AI/ML medical device, but rather a dental accessory used for shading zirconia dental restorations. Therefore, the information requested about acceptance criteria and study design from an AI/ML perspective is not applicable here.

However, I can provide the available information regarding the device's performance testing and comparison to a predicate device.

Performance Data (Non-Clinical) - Not AI/ML Specific

The performance data provided is for a dental coloring liquid, not an AI/ML device. The "acceptance criteria" in this context are implicitly met if the test results support substantial equivalence to the predicate device and comply with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, there are no "acceptance criteria" in the typical sense of metrics like sensitivity, specificity, or AUC. Instead, the device's performance is demonstrated through non-clinical bench testing to ensure safety and functionality, and its substantial equivalence to a predicate device is established by comparing characteristics.

Test Category	Acceptance Criteria (Implicit: Supports Substantial Equivalence to Predicate, meets standards)	Reported Device Performance
Shelf Life	Passed (implied)	Test results support substantial equivalence to the predicate device.
ISO 10993-5 Cytotoxicity	Passed (implied)	Test results support substantial equivalence to the predicate device.
ISO 10993-10 Sensitization & Irritation	Passed (implied)	Test results support substantial equivalence to the predicate device.
ISO 10993-11 Oral mucosa irritation	Passed (implied)	Test results support substantial equivalence to the predicate device.
Appearance	As expected/comparable to predicate (implied)	Test results support substantial equivalence to the predicate device.
Volume	As expected/comparable to predicate (implied)	Test results support substantial equivalence to the predicate device.
Packaging	As expected/comparable to predicate (implied)	Test results support substantial equivalence to the predicate device.
Uniformity	As expected/comparable to predicate (implied)	Test results support substantial equivalence to the predicate device.
Chemical Solubility	As expected/comparable to predicate (implied)	Test results support substantial equivalence to the predicate device.
pH	5.5-8.0	Reported Range: 5.5-8.0 (Subject Device) vs. 6.5-7.2 (Predicate)
Boiling Point	100°C	Reported: 100°C (Subject Device) vs. 100°C (Predicate)
Density	1.00-1.10 g/cm³	Reported Range: 1.00-1.10 g/cm³ (Subject Device) vs. 1.05-1.10 g/cm³ (Predicate)
Specific Gravity	1.00-1.10	Reported Range: 1.00-1.10 (Subject Device) vs. 1.05-1.10 (Predicate)
Solubility in Water	100%	Reported: 100% (Subject Device) vs. 100% (Predicate)

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The tests performed are non-clinical bench tests (e.g., in vitro biocompatibility, chemical analysis), not tests involving patient data or clinical samples in the way an AI/ML device would be evaluated.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here relates to the chemical and physical properties of the coloring liquid and its biocompatibility, which are determined by established scientific methods and laboratory testing, not by expert interpretation of images or patient data.

4. Adjudication Method

Not applicable. This is not a study involving human readers or interpretations needing adjudication.

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

Not applicable. This is a non-AI/ML dental accessory.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a non-AI/ML dental accessory.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is derived from:

Bench Test Results: Objective measurements from laboratory tests for physicochemical properties (pH, boiling point, density, solubility) and biocompatibility (cytotoxicity, sensitization, irritation, oral mucosa irritation) according to referenced standards (e.g., ISO 10993).
Predicate Device Characteristics: Comparison to an already cleared device's known characteristics and performance to establish substantial equivalence.

8. Sample Size for Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of Device and Performance Evaluation:

The DMAX Coloring Liquid family of products are water-based solutions with inorganic pigments used to shade zirconia dental restorations. Their premarket notification to the FDA focuses on demonstrating substantial equivalence to an existing predicate device (LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID). This is achieved through:

Comparison of Device Characteristics: Showing similar indications for use, principle of operation, technology (water-based with inorganic pigments), prescription use, target population, general physical form, and sterility to the predicate.
Bench Testing: Non-clinical tests were conducted according to relevant standards (e.g., ISO 10993 for biocompatibility) for properties such as shelf life, cytotoxicity, sensitization, irritation, oral mucosa irritation, appearance, volume, packaging, uniformity, and chemical solubility. The document states that "All the test results support substantial equivalence to the predicate devices."
Physicochemical Property Comparison: Specific values for pH, boiling point, density, specific gravity, and water solubility were provided for both the subject device and the predicate device, indicating comparable profiles.

The differences noted (packaging volume, number of shades, shelf life/storage conditions) were deemed not to raise new questions of safety or effectiveness, particularly because the shelf life test results supported equivalence despite different storage duration/conditions.

Summary

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March 8, 2018

DMAX Co, Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620

Re: K173769

Trade/Device Name: DMAX Coloring Liquid: Chang's Liquid: Confident Coloring Liquid: CAMeleon Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 30, 2017 Received: December 11, 2017

Dear Priscilla Chung:

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, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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.

Mary S. Runner -S

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

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Indications for Use

510(k) Number (if known) K173769

Device Name

DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liquid

Indications for Use (Describe)

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) Summary

Date: Mar 07, 2018

Applicant / Submitter: 1.

DMAX CO., LTD.

37-26, Dasa-ro 71-gil, Dasa-eup, Dalseong-gun, Daegu, 42907, Republic of Korea

Contact Person: Hyeon Seok Cho

Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c @lkconsultinggroup.com

3. Device:

Proprietary Name:	DMAX Coloring LiquidChang's LiquidConfident Coloring LiquidCAMeleon Coloring Liquid
Common Name:	Liquid Stain for Dental Zirconium Prosthesis
Classification Name:	Porcelain Powder for Clinical Use
Classification:	Class II, 21 CFR 872.6660
Classification Product Code:	EIH

Predicate Device: 4.

LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090) by Talladium, Inc.

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5. Device Description:

The liquid has 45 shades are available in 15ml, 20ml, 30ml, 40ml and 100ml volumes. We offer the product in four different names: DMAX Coloring Liquid, Chang's Liquid, Confident Coloring Liquid, CAMeleon Coloring Liquid. They are just different names for the same products.

DMAX Coloring Liquid is available in 20ml, and 100ml volumes in 45 shades.
Chang's Liquid is available in 15ml and 40ml volumes in 45 shades. ●
Confident Coloring Liquid is available in 30ml volume in 45 shades. ●
CAMeleon Coloring Liquid is available in 20ml, 100ml volumes in 45 shades. .

6. Indications for Use:

DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liguid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

7. Performance Data(Non-Clinical):

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

· Shelf Life Test
ISO 10993-5 Cytotoxicity
· ISO 10993-10 Sensitization & Irritation
ISO 10993-11 Oral mucosa irritation
· Other bench testing Appearance, Volume, Packaging, Uniformity, Chemical Solubility

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8. Substantial Equivalence

The subject device is compared to the predicate device, LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID (K143090), in the table below .

	Subject device	Predicate device
Device Name	DMAX coloring liquidChang's liquidConfident coloring liquidCAMeleon coloring liquid	LUMINESSE® PRE-SINTERED ZIRCONIACOLORING LIQUID
510(k)	K173769	K143090
Product Code	EIH	EIH
Manufacturer	DMAX Co., Ltd.	Talladium, Inc.
Technology	Water-based with inorganicpigments	Water-based with inorganicpigments
Indication for Use	DMAX coloring liquid, Chang'sliquid, Confident coloring liquid,and CAMeleon coloring liquidcan be used as an accessoryto zirconium dioxide dentalrestorative material to provideindividual tooth (or teeth)shading. It is intended to be usedsolely by certified dentaltechnicians for fabrication ofzirconium dioxide restorationsfor individual dental patients.	Luminesse Pre-SinteredZirconia Coloring Liquid is adevice that can be used as anaccessory to zirconium dioxidedental restorative material suchas Luminesse ZR blanks toprovide individualized tooth (orteeth) shading. It is intended tobe used solely by certifieddental technicians forfabrication of all ceramicrestorations for individual dentalpatients.
Principles of Operation	Brush or immerse zirconiaceramic with coloring liquidbefore sintering	Brush or immerse zirconiaceramic with coloring liquidbefore sintering
Prescription Use	Prescription only	Prescription only
Target population	General, mostly adults	General, mostly adults
Type of Packaging	Liquid container	Liquid container
Packaging Volume(ml)	15,20,30,40,100	100 and 250
Shade	45 colors	16 colors
Storage Conditions	1 year at 2-28 °C	3-4 years at 4-10 °C
General Physical Form	Liquid	Liquid
Sterility	Non-Sterile	Non-Sterile
pH	5.5~8.0	6.5-7.2
Boiling Point	100°C	100°C
Density	1.00~1.10 g/cm^3	1.05-1.10 g/cm^3
Specific Gravity	1.00~1.10	1.05-1.10
Solubility in Water	100%	100%
Color	45 shades	VITA® - 16 shades
Odor	Characteristic odor	Characteristic odor

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The subject device is the same as the predicate device in the indications for use, principle of operation, and device characteristics. Both devices are water-based with inorganic pigments and employs brushing or immersing method for use.

The differences between the subject device and the predicate device are packaging volume and the number of shades offered. Another difference is shelf life and storage conditions; however, the shelf life test results of the subject device support that the subject device is substantially equivalent to the predict device.

9. Conclusion:

Based on the testing results, DMAX CO., LTD. concludes that the subject device is substantially equivalent 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.