Perfit CL

{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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. June 20, 2023 Vatech mcis Co., Ltd. % Dave Kim MTech Group 7505 Fannin St. Ste 610 Houston, Texas 77054 Re: K223029 Trade/Device Name: Perfit CL Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 22, 2023 Received: May 22, 2023 Dear Dave Kim: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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-regulatoryassistance/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, # Bobak Shirmohammadi -S For Michael E. Adjodha, M. ChE., 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223029 Device Name Perfit CL Indications for Use (Describe) Perfit CL can be used as an accessory to zirconium dioxide dental 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) | <input checked="" type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------|----------------------------------------------| | <input type="checkbox"/> | Over-The-Counter Use (21 CFR 801 Subpart C) | ### 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 ### K223029 The following 510(k) summary is being submitted as required by 21 CFR 807.92; | 5.1 Submitter: | Vatech mcis Co., Ltd.<br>C-Dong, 2544, Nambuk-daero, Idong-eup, Cheoin-gu,<br>Yongin-si, Gyeonggi-do, South Korea (17137)<br>Phone No. +82-31-8005-1855<br>Fax No. +82-31-8005-1888 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kim, Gyeong Rok<br>Phone: +82-31-8005-1855<br>E-mail: gyeongrok.kim@vatechmcis.com | | Official Correspondent: | Dave Kim, MBA<br>Mtech Group<br>7505 Fannin St. Suite 610, Houston, TX<br>Tel: 713-467-2607<br>E mail: davekim@mtechgroupllc.com | | Date Prepared: | June 18, 2023 | #### 5.2 Device Identification | Device Trade Name | Perfit CL | |-----------------------------|--------------------------------------------------------| | Common Name | Coloring liquid for dental zirconium oxide ceramic | | Classification Name, Number | Porcelain Powder for Clinical Use (21 CFR<br>872.6660) | | Device Classification | II | | Product Code | EIH | #### 5.3 Predicated or legally marketed devices which are substantially equivalent · Primary Predicate device: K173769, "DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid", manufactured by "DMAX Co, Ltd." #### 5.4 Device Description This medical device is used to color the zirconia pre- sintered body, and it is a color solution that makes the color similar to natural teeth by using a brush and immersion. #### ર્સ્ડ Statement of Indication for use Perfit CL 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. {4}------------------------------------------------ #### Non-clinical Test Conclusion 5.6 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 10993-3- Genotocixity (Ames test) & Genotocixity (Micronucleus) - = ISO 10993-5- Cytotoxicity - ISO 10993-10 Sensitization & Irritation - = ISO 10993-11 Acute systemic toxicity (Oral) - = Other bench testing- Appearance, Volume, Packaging, Dissolution analysis, Color stability Bench test results allowed to conclude that Perfit CL is substantially equivalent to the predicate devices for its intended use. #### 5.7 Clinical Test Conclusion Clinical testing was not required for this submission. #### 5.8 Technical Characteristics and Substantial Equivalence The following table shows similarities and differences of Packaging Volume, Shade and Storage Conditions between our device and the predicate devices. | No. | Item | Subject Device | Predicate Device | Remark | |-----|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Device Name | Perfit CL | DMAX coloring liquid<br>Chang's liquid<br>Confident coloring liquid<br>CAMeleon coloring liquid | | | 2 | Manufacturer | Vatech mcis Co., Ltd | DMAX Co., Ltd. | | | 3 | 510(k) Number | K223029 | K173769 | | | 4 | Product Code | EIH | EIH | | | 5 | Class | II | II | | | 6 | Review Panel | Dental | Dental | | | 7 | Technology | Water-based with<br>inorganic<br>pigments | Water-based with<br>inorganic<br>pigments | Same as predicate | | 8 | Indications for<br>Use | Perfit CL can be used as an<br>accessory to zirconium<br>dioxide dental restorative<br>material to provide<br>individual tooth (or teeth)<br>shading. It is intended to be<br>used solely by certified<br>dental technicians for<br>fabrication of zirconium<br>dioxide restorations for<br>individual dental patients | DMAX coloring liquid,<br>Chang's liquid, Confident<br>coloring liquid, and<br>CAMeleon coloring liquid<br>can be used as an accessory<br>to zirconium dioxide dental<br>restorative material to<br>provide individual tooth<br>(or teeth) shading. It is<br>intended to be used solely<br>by certified dental<br>technicians for fabrication<br>of zirconium dioxide<br>restorations for individual<br>dental patients. | Same as predicate | | 9 | Principles of<br>Operation | Brush or immerse zirconia<br>ceramic with coloring<br>liquid before sintering | Brush or immerse zirconia<br>ceramic with coloring<br>liquid before sintering | Same as predicate | | 10 | Prescription Use | Prescription only | Prescription only | Same as predicate | | 11 | Target<br>population | General, mostly adults | General, mostly adults | Same as predicate | | 12 | Type of<br>Packaging | Liquid container | Liquid container | Same as predicate | | 13 | Packaging<br>Volume(ml) | 20 and 50mL | 15,20,30,40 and 100mL | No significant difference.<br>The dose is different but it<br>can be differentiated<br>depending on experts'<br>determination. That is,<br>dose is not relevant to<br>clinical performance and<br>safety. | | 14 | Shade | 27 colors | 45 colors | No significant difference.<br>The shade is different but<br>it can be differentiated<br>depending on experts'<br>determination. That is,<br>dose is not relevant to<br>clinical performance and<br>safety. | | 15 | Storage<br>Conditions | 2 years at 0-25 °C | 1 year at 2-28 °C | No significant difference.<br>The storage temperature<br>is a little different but the<br>storage temperature does<br>not cause any clinical<br>performance and safety<br>issue will not be caused<br>by the storage<br>temperature if stored at<br>the recommended<br>storage temperature. | | 16 | General<br>Physical<br>Form | Liquid | Liquid | Same as predicate | | 17 | Sterility | Non-Sterile | Non-Sterile | Same as predicate | | 18 | pH | 5.5~8.0 | 5.5~8.0 | Same as predicate | | 19 | Boiling Point | 100°C | 100°C | Same as predicate | | 20 | Density | 1.00~1.10 g/cm^3 | 1.00~1.10 g/cm^3 | Same as predicate | | 21 | Specific Gravity<br>(Relative Density) | 1.00~1.10 | 1.00~1.10 | Same as predicate | | 22 | Solubility in<br>Water | 100% | 100% | Same as predicate | | 24 | Biocompatibility<br>y Testing | Tested to ISO 10993-1 | Tested to ISO 10993-1 | Same as predicate | | 25 | Performance<br>Testing | Tested to ISO 6872 | Tested to ISO 6872 | Same as predicate | Table 1. General Device Characteristics Comparison Table {5}------------------------------------------------ ## Submitter: Vatech mcis Co., Ltd Perfit CL Premarket Notification: Traditional 510(k) {6}------------------------------------------------ The subject device is substantially equivalent to the predicate device, DMAX coloring liquid, Chang's liquid, Confident coloring liquid, CAMeleon coloring liquid, (K173769) made by DMAX Co., Ltd. Both the device has the same indications for Use and technological characteristics. They even have the same pH, boiling point, density and specific gravity range. Both devices are soluble in water. The raw material composition rate might be different between the devices, however, the subject device meets the requirements ISO 10993, therefore, this difference would not raise a question in substantial equivalence. | 5.9 | Conclusion | Based on the testing results, Vatech mcis Co., Ltd concludes that the<br>subject device is substantially equivalent to the predicate device. | |------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5.10 | Declarations | This summary includes only information that is also covered in the<br>body of the 510(k).<br>This summary does not contain any puffery or unsubstantiated<br>labeling claims. |