MAZIC Claro CAD and MAZIC Claro Press

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July 1, 2021 Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620 Re: K203672 Trade/Device Name: MAZIC Claro CAD and MAZIC Claro Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 1, 2021 Received: May 7, 2021 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. 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/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 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, Michael E. Adjodha, M.ChE. 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) K203672 Device Name MAZIC Claro CAD and MAZIC Claro Press #### Indications for Use (Describe) MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☒</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> | #### 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 (k203672) This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: June 28, 2021 ## 1. 510K Applicant / Submitter: Vericom Co., Ltd. 48,Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do, 200-944, Republic of Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883 #### 2. Submission Contact Person LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com ## 3. Device - Proprietary Name: MAZIC Claro CAD and MAZIC Claro Press . - Common Name: Dental Frame Material for Dental prosthesis - Classification: Porcelain Powder for Clinical Use, Class II (21 CFR 872.6660) ● - Product Code: EIH . - . Review Panel: Dental ## 4. Predicate Device IPS E.MAX PRESS (K120134) by Ivoclar Vivadent AG IPS E.MAX CAD (K051705) by Ivoclar Vivadent AG ## 5. Description: The MAZIC Claro Press, dental glass ceramic ingot, is to make dental restorative prosthesis such as inlays, onlays, veneers, crowns and bridges. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through regular press process. The MAZIC Claro CAD, dental glass ceramic block, is to make dental restorative prosthesis such as inlays, onlays, veneers and crowns. Having a variety of shade, the user can choose a {4}------------------------------------------------ suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM. # 8. Indications for Use MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges. # 9. Substantial Equivalence Discussion: # 9.1. MAZIC Claro Press | | Subject Device | Predicate Device | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | MAZIC Claro Press | IPS E.MAX PRESS | | Manufacturer | VERICOM CO., LTD. | Ivoclar Vivadent AG | | 510K Number | K203672 | K120134 | | Product Code | EIH | EIH | | | MAZIC Claro Press is an all-ceramic system for the creation of | IPS e.max Press and IPS e.max Press Multi is an all-ceramic system for the creation of | | Indications for Use | Occlusal veneers<br>Thin Veneers<br>Veneers<br>Inlays<br>Onlays<br>Crowns in the anterior and posterior region<br>3-unit bridges in the anterior region<br>3-unit bridges in the premolar region up to the second premolar as the terminal abutment<br>Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. | Occlusal veneers<br>Thin Veneers<br>Veneers<br>Inlays<br>Onlays<br>Crowns in the anterior and posterior region<br>3-unit bridges in the anterior region<br>3-unit bridges in the premolar region up to the second premolar as the terminal abutment<br>Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. | | Type and class<br>according to ISO6872 | - Type II<br>- Class 3.a) Monolithic ceramic for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration adhesively or non-adhesively cemented. | - Type II<br>- Class 3.a) Monolithic ceramic for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration adhesively or non-adhesively cemented. | | Chemical<br>Compositions | SiO2<br>Li2O<br>K2O<br>MgO<br>ZnO<br>Al2O3<br>P2O5<br>ZrO2<br>Other oxides | SiO2<br>Li2O<br>K2O<br>ZnO<br>P2O5<br>ZrO2<br>Other oxides | | Summary of sizes and<br>shades | Form of Ingots:<br>Ø12.7 x 10 mm, Ø12.7 x 20 mm | Form of Ingots:<br>Ø12.7 x 10 mm, Ø12.7 x 20 mm | | Shade | High translucency : 16 A-D and 4 Bleach shades<br>Low translucency : 16 A-D and 4 Bleach shades<br>Medium opacity : 5 shades<br>High opacity: 3 shades | High translucency : 16 A-D and 4 Bleach shades<br>Low translucency : 16 A-D and 4 Bleach shades<br>Medium opacity : 5 shades<br>High opacity: 3 shades | | Principle of operation | Fabricating restorations using hot press technique | Fabricating restorations using hot press technique | | Sterility | Non-sterile | Non-sterile | | Physical properties | Conforms to ISO 6872<br>Uniformity(Consistency),<br>Freedom of extraneous materials(Foreign materials),<br>Flexural strength<br>Chemical solubility<br>Linear thermal expansion/Coefficient of thermal expansion(CTE) | Conforms to ISO 6872<br>Flexural strength<br>Chemical solubility<br>Coefficient of thermal expansion(CTE)<br>Radiopacity | {5}------------------------------------------------ {6}------------------------------------------------ ## Substantial Equivalence Discussion The subject device has the same indications for use and the same principle of operation as the predicate device. Although the subject device and the predicate device might have a slight difference in raw material, the both devices produced after manufacturing process at high temperatures have SiO2, Li2O, K2O, ZnO and P2O5 as major ingredients. Despite this difference, the test results per ISO6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements. We also performed biocompatibility tests on the subject device and the test results show that it confirms the ISO 10993 requirements. Therefore, the difference does not raise a question in safety and effectiveness and the subject device is substantially equivalent to the predicate device. | | Subject Device | Predicate Device | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | MAZIC Claro CAD | IPS E.MAX CAD | | Manufacturer | VERICOM CO., LTD. | Ivoclar Vivadent AG | | 510K Number | K203672 | K051705 | | Product Code | EIH | EIH | | Indications for Use | MAZIC Claro Press is a CAD/CAM<br>machinable glass ceramic based on<br>lithium disilicate for the preparation of<br>full ceramic crowns, inlays, onlays, and<br>full ceramic 3-unit anterior bridges. | IPS e.max CAD is a CAD/CAM<br>machinable glass ceramic based on lithium<br>disilicate for the preparation of full<br>ceramic crowns, inlays, onlays, and full<br>ceramic 3-unit anterior bridges. | | Type and class<br>according to ISO6872 | - Type II<br>- Class 3.a) Monolithic ceramic for<br>single-unit anterior or posterior<br>prostheses and for three-unit<br>prostheses not involving molar<br>restoration adhesively or non-<br>adhesively cemented. | - Type II<br>- Class 3.a) Monolithic ceramic for<br>single-unit anterior or posterior<br>prostheses and for three-unit<br>prostheses not involving molar<br>restoration adhesively or non-<br>adhesively cemented. | | Chemical<br>Compositions | SiO2<br>Li2O<br>K2O<br>MgO<br>ZnO<br>Al2O3<br>P2O5<br>ZrO2<br>Other oxides | SiO2<br>Li2O<br>K2O<br>MgO<br>ZnO<br>Al2O3<br>P2O5<br>ZrO2<br>Other oxides | | Summary of sizes and<br>shapes | Form of Blocks:<br>12 x 10 x 15 mm, 14 x 12 x 18 mm,<br>14.5 x 14.5 x 32 mm, 15.2 x 15 x 38 mm | Form of Blocks:<br>12.5 x 10.4 x 15 mm, 14.5 x 12.4 x 18 mm,<br>15.8 x 17.8 x 18 mm, 14.5 x 14.5 x 32 mm,<br>15.2 x 15.2 x 38 mm | # 9.2. MAZIC Claro CAD {7}------------------------------------------------ | | | High translucency : 16 A-D and 4 Bleach<br>shades | |------------------------|-------------------------------------------------------------------|-----------------------------------------------------| | Shade | High translucency : 3 A shades | | | | Low translucency : 3 A shades | Low translucency : 16 A-D and 4 Bleach<br>shades | | | Medium opacity : 3 shades | Medium opacity : 5 shades | | | Bleach : 2 shades | Opalescence: 2 shades | | Principle of operation | Fabricating restorations using | Fabricating restorations using CAD/CAM<br>technique | | | CAD/CAM technique | | | Sterility | Non-sterile | Non-sterile | | Physical properties | Conforms to ISO 6872 | Conforms to ISO 6872 | | | Uniformity, | Flexural strength | | | Freedom of extraneous materials, | Chemical solubility | | | Flexural strength | Coefficient of thermal expansion(CTE) | | | Chemical solubility | Radiopoacity | | | Linear thermal expansion/Coefficient of<br>thermal expansion(CTE) | | | | Radadiopacity(Radiation emission) | | Substantial Equivalence Discussion The subject device has the same indications for use and the same principle of operation as the predicate device. Although the subject device and the predicate device might have a slight difference in raw material, the both devices produced after manufacturing process at high temperatures have SiO2, Li2O, K2O, MgO, ZnO, Al2O3, P2O5 and ZrO2 as major ingredients. Despite this difference, the test results per ISO6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements. Another difference is the shades the devices offer. This difference is also related to raw materials. We also performed biocompatibility tests on the subject device and the test results show that it confirms the ISO 10993 requirements. Therefore, the differences do not raise a question in safety and effectiveness and the subject device is substantially equivalent to the predicate device. # 10. Performance Tests (Non-clinical) | No | Test | Standard | |----|-----------------------------------------|----------| | 1 | Uniformity | ISO 6872 | | 2 | Freedom from extraneous<br>materials | ISO 6872 | | 3 | Flexural strength | ISO 6872 | | 4 | Chemical solubility | ISO 6872 | | 5 | Radioactivity | ISO 6872 | | 6 | Linear thermal expansion<br>coefficient | ISO 6872 | | 7 | Glass transition temperature | ISO 6872 | - . Performance Tests in accordance with ISO 6872 {8}------------------------------------------------ | No<br>. | Test | Standard | |---------|-------------------------------------------|-------------| | 1 | Cytotoxicity<br>(Agar diffusion) | ISO10993-5 | | 2 | Sensitization | ISO10993-10 | | 3 | Acute systemic toxicity<br>(Oral) | ISO10993-11 | | 4 | Oral mucosa irritation | ISO10993-10 | | 5 | Bacterial reverse mutation<br>(Ames test) | ISO10993-3 | - Biocompatibility Tests in accordance with ISO 10993 . The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences. #### 11. Conclusions: Based on the information provided in this premarket notification, Vericom Co., Ltd. concludes that the MAZIC Claro CAD and MAZIC Claro Press are substantially equivalent to the predicate device as described herein in.