MAZIC Duro

K163346 · Vericom Co., Ltd. · EBF · Mar 17, 2017 · Dental

Device Facts

• Record ID: K163346
• Device Name: MAZIC Duro
• Applicant: Vericom Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Mar 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of inlays, onlays, veneers and crowns

Device Story

MAZIC Duro is a radiopaque, hybrid ceramic, resin-based composite block used for dental restorations. Intended for use by dental professionals in CAD/CAM milling procedures to create inlays, onlays, veneers, and crowns. The device is matched to the patient's tooth shade. It serves as a restorative material for anterior and posterior teeth. Benefits include providing a durable, biocompatible, and aesthetically matched restoration for patients requiring dental repair.

Clinical Evidence

Bench testing only. Performance evaluated via ISO 4049 testing including compressive strength (534.40 MPa), flexural strength (213.30 MPa), elastic modulus (10.17 GPa), radio-opacity, Vickers microhardness, water sorption, and solubility. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), genotoxicity (ISO 10993-3), oral mucosa irritation (ISO 10993-10), sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11).

Technological Characteristics

Radiopaque, hybrid ceramic, resin-based composite block. Dimensions: Rectangular (10.2x12.2x15mm, 14.5x14.5x18mm) and Disc (95/98/100mm diameter, 8-14mm thickness). Performance standards: ISO 4049. Biocompatibility standards: ISO 10993-1, -3, -5, -10, -11. Non-sterile. Storage: 2-27°C, avoid sunlight.

Indications for Use

Indicated for the fabrication of inlays, onlays, veneers, and crowns in dental patients.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• CERASMART (K133824)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

Vericom Co., Ltd. Myung-Hwan Oh R&d Director 48 Toegyegongdan 1-gil Chuncheon-si, 200-944 REPUBLIC OF KOREA

Re: K163346

Trade/Device Name: Mazic Duro Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, POW Dated: December 28, 2016 Received: December 30, 2016

Dear Myung-Hwan Oh:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runno, DDS, MA

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

Device Name MAZICTM Duro

Indications for Use (Describe)

· Fabrication of inlays, onlays, veneers and crowns

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) 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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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# 510(K) SUMMARY

# MAZIC™Duro

#### Date:

## I. SUBMITTER

Vericom Co., Ltd. 48 Toegyegongdan 1-gil, Chuncheon-si, Gangwon-do 200-944, Korea Tel: [phone] Fax: [phone]

Contact Name: Myung-Hwan Oh Email: [e-mail]

### II. DEVICE

| Name of Device: | MAZIC™ Duro |
|----------------------|----------------------------|
| Regulation Name: | Tooth shade resin material |
| Classification Name: | Tooth shade resin material |
| Regulatory Class: | 2 |
| Product Code: | EBF |

#### III. Predicate Device

K133824, CERASMART, GC AMERICA INC.

# IV. DEVICE DESCRIPTION

MAZIC™Duro, a dental restorative material, is a radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns. The device can be matched to the patient's tooth shade and is intended for use in dental CAD/CAM milling procedures.

## V. INDICATIONS FOR USE

· Fabrication of inlays, onlays, veneers and crowns

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| | | Subject Device | Predicate Device | Summary |
|---------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | MAZIC™ Duro | CERASMART | - |
| Manufacturer | | Vericom Co., Ltd. | GC AMERICA INC. | - |
| 510(k) Number | | New | K133824 | - |
| Intended user | | Dental professionals | Dental professionals | - |
| Similarity | Description | MAZIC™ Duro, a dental<br>restorative material, is a<br>radiopaque, block type,<br>hybrid ceramic that is<br>intended for the<br>fabrication of inlays,<br>onlays, veneers and<br>crowns. The device can<br>be matched to the<br>patient's tooth shade<br>and is intended for use<br>in dental CAD/CAM<br>milling procedures. | CERASMART is a pre-<br>cured composite block<br>for milling CAD/CAM<br>indirect restorations.<br>The milled device is used<br>for the restorations of<br>both anterior and<br>posterior teeth. | Description<br>of<br>subject device<br>and predicate<br>device is very<br>similar; pre-curd<br>composite block<br>for milling by<br>dental<br>CAD/CAM |
| | Indications for<br>Use | Fabrication of inlays,<br>onlays, veneers and<br>crowns | The product is indicated<br>for inlays, onlays,<br>veneers and full crown<br>restorations, including<br>crowns on implants | Both device are<br>used for inlays,<br>onlays, veneers<br>and crowns. |
| | Design | Pre-cured block | Pre-cured block | Both<br>devices<br>are provided in<br>pre-curd block |
| | Chemical<br>composition | Resin base | Resin base | Both<br>devices<br>are resin based<br>composite<br>block. |
| | Physical<br>and<br>performance<br>properties | ISO 4049<br>-Compressive strength:<br>534.40 MPa<br>-Flexural Strength:<br>213.30 MPa<br>-Elastic modulus: 10.17<br>GPa<br>-Radio-opacity: 2.4 step<br>wedge<br>-Vicker'smicrohardness:<br>85.28 HV0.2<br>-Water sorption: 15.51<br>µg/cm2<br>-Solubility: 1.90 µg/cm2 | ISO 4049<br>-Compressive strength:<br>501.76 MPa<br>-Flexural Strength:<br>207.91 MPa<br>-Elastic modulus: 9.15<br>GPa<br>-Radio-opacity : 2.6 step<br>wedge<br>-Vicker'smicrohardness:<br>70.97 HV0.2<br>-Water sorption: 20.67<br>µg/cm3<br>-Solubility : 2.10 µg/cm2 | Physical<br>and<br>performance<br>properties<br>of<br>the subjective<br>device<br>is<br>substantial<br>equivalent<br>to<br>predicate<br>device. |
| | Biocompatibil<br>ity | -Cytotoxicity(Agar<br>diffusion)<br>-Acute systemic<br>toxicity(Oral) | Device is biocompatible<br>when used as directed<br>by dental professionals<br>per ISO 10993-1.<br>-Acute systemic<br>toxicity(Oral) | Both<br>devices<br>are<br>biocompatible. |
| | | -Oral mucosa irritation<br>-Sensitization(GPMT)<br>-Genotoxicity(Ames) | | |
| | Sterilization | Non-sterile | Non-sterile | Same |
| | Storage<br>condition | Avoid exposure to the<br>sunlight.<br>Store at room<br>temperature(2-27°C). | Recommended for<br>optimal performance,<br>store at room<br>temperature(4-25°C /<br>39.2-77.0°F) away from<br>direct sunlight and high<br>humidity. | Both devices<br>are<br>recommended<br>at room<br>temperature<br>away from<br>sunlight. |
| | Shelf Life | 5 years | 5 years | Same |
| Difference | Shade | 30 shades(A1 HT, A2 HT,<br>A3 HT, B1 HT, B2 HT, B3<br>HT, C1 HT, C2 HT, C3 HT,<br>D2 HT, D3 HT, E HT, A1<br>LT, A2 LT, A3 LT, A3.5 LT,<br>A4 LT, B1 LT, B2 LT, B3<br>LT, B4 LT, C1 LT, C2 LT,<br>C3 LT, C4 LT, D2 LT, D3<br>LT, D4 LT, W1 LT, W2 LT) | 33 shades(A1 HT, A2 HT,<br>A3 HT, A3.5 HT, A4 HT,<br>B1 HT, B2 HT, B3 HT, B4<br>HT, C1 HT, C2 HT, C3<br>HT, C4 HT, D2 HT, D3 HT,<br>D4 HT, A1 LT, A2 LT, A3<br>LT, A3.5 LT, A4 LT, B1 LT,<br>B2 LT, B3 LT, B4 LT,<br>C1 LT, C2 LT, C3 LT, C4<br>LT, D2 LT, D3 LT, D4 LT,<br>BL) | Shade is an<br>option that is<br>selected<br>according to<br>patient's teeth<br>color. |
| | Size | -Rectangular type:<br>[12]10.2*12.2*15,<br>[14L]14.5*14.5*18<br>-Disc type:<br>Φ98*8T/10T/12T/14T,<br>Φ100*8T/10T/12T/14T,<br>Φ95*8T/10T/12T/14T | 3 sizes(12, 14, 14L) | Size is an option<br>that is selected<br>according to<br>patient's<br>application<br>region. The disc<br>type of subject<br>device provide<br>several<br>restorations |

# VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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#### VII. NON-CLINICAL PERFORMANCE TESTING

MAZIC™ Duro and the predicate device, CERASMART were tested for the nonclinical performance including compressive strength, flexural strength, elastic modulus, radio-opacity, vicker's micro hardness, water sorption, and solubility.

All of test results obtained from these tests indicated that MAZIC™ Duro is substantially equivalent to the predicate device, CERASMART, in terms of physical properties and performance.

The biocompatibility evaluation for the MAZIC™ Duro was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing''' May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:

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- Cytotoxicity(Agar diffusion), ISO 10993-5[2009] ·
- Genotoxicity(Ames), ISO 10993-3[2003] •
- Oral mucous Irritation, ISO 10993-10[2010]
- Sensitization(GPMT), ISO 10993-10[2010]
- . Acute systemic toxicity, ISO 10993-11[2006]

The results of test indicated that MAZIC™ Duro is considered to be biocompatible and therefore equivalent with its predicate device, CERASMART, that considered biocompatibility per ISO 10993-1.

#### VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject device is similar to predicate device in terms of indication for use, design, chemical composition, physical properties and performance etc. The subject device consists of resin base composite block, as is the predicate device. The physical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing.

The variety of shades and sizes are different between subject device and predicate device.

#### IX. CONCLUSIONS

The indications and technological characteristics of MAZIC™ Duro are very similar to predicate device. Therefore, MAZIC™ Duro is substantially equivalent to the identified predicate device.