(197 days)
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.
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 suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.
This document describes the acceptance criteria and the study proving the device meets those criteria for the MAZIC Claro CAD and MAZIC Claro Press dental materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for both MAZIC Claro CAD and MAZIC Claro Press are based on conformance to ISO 6872: Dental ceramic. The reported device performance indicates that both devices conform to this standard for the specified physical and chemical properties.
| Acceptance Criterion (Standard) | MAZIC Claro Press Performance | MAZIC Claro CAD Performance |
|---|---|---|
| Uniformity (ISO 6872) | Conforms | Conforms |
| Freedom from extraneous materials (ISO 6872) | Conforms | Conforms |
| Flexural strength (ISO 6872) | Conforms | Conforms |
| Chemical solubility (ISO 6872) | Conforms | Conforms |
| Radioactivity (ISO 6872) | Conforms | Conforms |
| Linear thermal expansion coefficient (ISO 6872) | Conforms | Conforms |
| Glass transition temperature (ISO 6872) | Conforms | Not explicitly listed for CAD, but general conformance implied |
| Biocompatibility (ISO 10993-5, -10, -11, -3) | Confirmed (see tests below) | Confirmed (see tests below) |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance tests or the data provenance (country of origin, retrospective/prospective). The tests were conducted according to ISO standards, implying controlled laboratory conditions.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This submission is for dental materials, and the "ground truth" is established through standardized physical, chemical, and biocompatibility testing, not through expert radiological or clinical interpretation of images.
4. Adjudication Method
Not applicable, as this is for material testing, not diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that involves human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is for dental materials, not an algorithm. The performance is based on the material's inherent physical and chemical properties.
7. Type of Ground Truth Used
The ground truth used for these devices is established by international standards for dental ceramics and biocompatibility:
- ISO 6872 (Dental ceramic) for physical and chemical properties.
- ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of material performance testing for these dental ceramics. The material itself is the subject of the performance tests.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for these dental materials. The "ground truth" for evaluating the device's performance is the adherence to the established parameters and limits defined in the ISO 6872 and ISO 10993 standards. The performance tests are designed to measure these parameters directly.
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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
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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
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Indications for Use
510(k) Number (if known)
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) | ☒ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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
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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 veneersThin VeneersVeneersInlaysOnlaysCrowns in the anterior and posterior region3-unit bridges in the anterior region3-unit bridges in the premolar region up to the second premolar as the terminal abutmentCrown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. | Occlusal veneersThin VeneersVeneersInlaysOnlaysCrowns in the anterior and posterior region3-unit bridges in the anterior region3-unit bridges in the premolar region up to the second premolar as the terminal abutmentCrown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. |
| Type and classaccording to ISO6872 | - Type II- 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- 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. |
| ChemicalCompositions | SiO2Li2OK2OMgOZnOAl2O3P2O5ZrO2Other oxides | SiO2Li2OK2OZnOP2O5ZrO2Other oxides |
| Summary of sizes andshades | Form of Ingots:Ø12.7 x 10 mm, Ø12.7 x 20 mm | Form of Ingots:Ø12.7 x 10 mm, Ø12.7 x 20 mm |
| Shade | High translucency : 16 A-D and 4 Bleach shadesLow translucency : 16 A-D and 4 Bleach shadesMedium opacity : 5 shadesHigh opacity: 3 shades | High translucency : 16 A-D and 4 Bleach shadesLow translucency : 16 A-D and 4 Bleach shadesMedium opacity : 5 shadesHigh 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 6872Uniformity(Consistency),Freedom of extraneous materials(Foreign materials),Flexural strengthChemical solubilityLinear thermal expansion/Coefficient of thermal expansion(CTE) | Conforms to ISO 6872Flexural strengthChemical solubilityCoefficient of thermal expansion(CTE)Radiopacity |
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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/CAMmachinable glass ceramic based onlithium disilicate for the preparation offull ceramic crowns, inlays, onlays, andfull ceramic 3-unit anterior bridges. | IPS e.max CAD is a CAD/CAMmachinable glass ceramic based on lithiumdisilicate for the preparation of fullceramic crowns, inlays, onlays, and fullceramic 3-unit anterior bridges. |
| Type and classaccording to ISO6872 | - Type II- Class 3.a) Monolithic ceramic forsingle-unit anterior or posteriorprostheses and for three-unitprostheses not involving molarrestoration adhesively or non-adhesively cemented. | - Type II- Class 3.a) Monolithic ceramic forsingle-unit anterior or posteriorprostheses and for three-unitprostheses not involving molarrestoration adhesively or non-adhesively cemented. |
| ChemicalCompositions | SiO2Li2OK2OMgOZnOAl2O3P2O5ZrO2Other oxides | SiO2Li2OK2OMgOZnOAl2O3P2O5ZrO2Other oxides |
| Summary of sizes andshapes | Form of Blocks:12 x 10 x 15 mm, 14 x 12 x 18 mm,14.5 x 14.5 x 32 mm, 15.2 x 15 x 38 mm | Form of Blocks:12.5 x 10.4 x 15 mm, 14.5 x 12.4 x 18 mm,15.8 x 17.8 x 18 mm, 14.5 x 14.5 x 32 mm,15.2 x 15.2 x 38 mm |
9.2. MAZIC Claro CAD
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| High translucency : 16 A-D and 4 Bleachshades | ||
|---|---|---|
| Shade | High translucency : 3 A shades | |
| Low translucency : 3 A shades | Low translucency : 16 A-D and 4 Bleachshades | |
| Medium opacity : 3 shades | Medium opacity : 5 shades | |
| Bleach : 2 shades | Opalescence: 2 shades | |
| Principle of operation | Fabricating restorations using | Fabricating restorations using CAD/CAMtechnique |
| 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 ofthermal 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 extraneousmaterials | ISO 6872 |
| 3 | Flexural strength | ISO 6872 |
| 4 | Chemical solubility | ISO 6872 |
| 5 | Radioactivity | ISO 6872 |
| 6 | Linear thermal expansioncoefficient | ISO 6872 |
| 7 | Glass transition temperature | ISO 6872 |
- . Performance Tests in accordance with ISO 6872
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| No. | Test | Standard |
|---|---|---|
| 1 | Cytotoxicity(Agar diffusion) | ISO10993-5 |
| 2 | Sensitization | ISO10993-10 |
| 3 | Acute systemic toxicity(Oral) | ISO10993-11 |
| 4 | Oral mucosa irritation | ISO10993-10 |
| 5 | Bacterial reverse mutation(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.
§ 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.