DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) 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. Type of Use (Select one or both, as applicable) | <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 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 Liquid<br>Chang's Liquid<br>Confident Coloring Liquid<br>CAMeleon 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. {4}------------------------------------------------ #### 5. 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. - 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 {5}------------------------------------------------ #### 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 liquid<br>Chang's liquid<br>Confident coloring liquid<br>CAMeleon coloring liquid | LUMINESSE® PRE-<br>SINTERED ZIRCONIA<br>COLORING LIQUID | | 510(k) | K173769 | K143090 | | Product Code | EIH | EIH | | Manufacturer | DMAX Co., Ltd. | Talladium, Inc. | | Technology | Water-based with inorganic<br>pigments | Water-based with inorganic<br>pigments | | Indication for Use | DMAX coloring liquid, Chang's<br>liquid, Confident coloring liquid,<br>and CAMeleon coloring liquid<br>can be used as an accessory<br>to zirconium dioxide dental<br>restorative material to provide<br>individual tooth (or teeth)<br>shading. It is intended to be used<br>solely by certified dental<br>technicians for fabrication of<br>zirconium dioxide restorations<br>for individual dental patients. | Luminesse Pre-Sintered<br>Zirconia Coloring Liquid is a<br>device that can be used as an<br>accessory to zirconium dioxide<br>dental restorative material such<br>as Luminesse ZR blanks to<br>provide individualized tooth (or<br>teeth) shading. It is intended to<br>be used solely by certified<br>dental technicians for<br>fabrication of all ceramic<br>restorations for individual dental<br>patients. | | Principles of Operation | Brush or immerse zirconia<br>ceramic with coloring liquid<br>before sintering | Brush or immerse zirconia<br>ceramic with coloring liquid<br>before 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 | {6}------------------------------------------------ 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.