(197 days)
Not Found
No
The summary describes dental glass ceramic materials and their intended use in creating dental prostheses through traditional pressing or CAD/CAM milling processes. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is used to create dental restorative prostheses (e.g., crowns, veneers, bridges), which are replacements for damaged or missing dental structures, rather than directly treating a disease or condition.
No
The device description indicates that it is a dental glass ceramic system used to create dental restorative prostheses like crowns, veneers, inlays, and onlays, not to diagnose a condition.
No
The device description clearly states it is a dental glass ceramic ingot and block, which are physical materials used to create dental prostheses. It describes manufacturing processes like pressing and milling, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for creating dental restorative prostheses (veneers, inlays, onlays, crowns, bridges). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a dental glass ceramic material used to fabricate dental prostheses. It's a material for creating a physical restoration, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosing a disease or condition.
- Performance Studies: The performance studies focus on the physical and chemical properties of the material (flexural strength, solubility, biocompatibility), which are relevant to its use as a dental restorative material, not for diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device 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 suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Tests (Non-clinical) conducted per ISO 6872:
- Uniformity
- Freedom from extraneous materials
- Flexural strength
- Chemical solubility
- Radioactivity
- Linear thermal expansion coefficient
- Glass transition temperature
Biocompatibility Tests conducted per ISO 10993:
- Cytotoxicity (Agar diffusion) - ISO10993-5
- Sensitization - ISO10993-10
- Acute systemic toxicity (Oral) - ISO10993-11
- Oral mucosa irritation - ISO10993-10
- Bacterial reverse mutation (Ames test) - ISO10993-3
Key Results: 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. Biocompatibility tests confirm ISO 10993 requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IPS E.MAX PRESS (K120134), IPS E.MAX CAD (K051705)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
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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
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 | |
| 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. | 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. | ||
| Type and class | ||
| according 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. |
| Chemical
Compositions | SiO2
Li2O
K2O
MgO
ZnO
Al2O3
P2O5
ZrO2
Other oxides | SiO2
Li2O
K2O
ZnO
P2O5
ZrO2
Other oxides |
| Summary of sizes and
shades | 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 shades
Low translucency : 16 A-D and 4 Bleach shades
Medium opacity : 5 shades
High opacity: 3 shades | High translucency : 16 A-D and 4 Bleach shades
Low translucency : 16 A-D and 4 Bleach shades
Medium opacity : 5 shades
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
Uniformity(Consistency),
Freedom of extraneous materials(Foreign materials),
Flexural strength
Chemical solubility
Linear thermal expansion/Coefficient of thermal expansion(CTE) | Conforms to ISO 6872
Flexural strength
Chemical solubility
Coefficient of thermal expansion(CTE)
Radiopacity |
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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 | |
| machinable glass ceramic based on | ||
| lithium disilicate for the preparation of | ||
| full ceramic crowns, inlays, onlays, and | ||
| full ceramic 3-unit anterior bridges. | IPS e.max 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 and class | ||
| according 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. |
| Chemical
Compositions | SiO2
Li2O
K2O
MgO
ZnO
Al2O3
P2O5
ZrO2
Other oxides | SiO2
Li2O
K2O
MgO
ZnO
Al2O3
P2O5
ZrO2
Other oxides |
| Summary of sizes and
shapes | 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
7
| | | High translucency : 16 A-D and 4 Bleach
shades |
|------------------------|-------------------------------------------------------------------|-----------------------------------------------------|
| Shade | High translucency : 3 A shades | |
| | Low translucency : 3 A shades | Low translucency : 16 A-D and 4 Bleach
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
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
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 | |
| materials | ISO 6872 | |
| 3 | Flexural strength | ISO 6872 |
| 4 | Chemical solubility | ISO 6872 |
| 5 | Radioactivity | ISO 6872 |
| 6 | Linear thermal expansion | |
| coefficient | 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.