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.

AI/ML Overview

The provided text describes the 510(k) summary for the dental device MAZIC™ Duro, which is a tooth shade resin material. It focuses on demonstrating substantial equivalence to a predicate device (CERASMART) rather than proving performance against specific acceptance criteria for an AI/algorithm-based medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI evaluation (sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details cannot be extracted from this document, as it is not relevant to an AI/algorithm-based device. The document describes a physical material, and its performance is evaluated through material properties and biocompatibility as opposed to AI accuracy metrics.

The document states:

Device Type: MAZIC™ Duro is a "radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns." It's a dental restorative material used in CAD/CAM milling procedures.
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."
Biocompatibility: Evaluated according to ISO 10993 standards.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/algorithm-based device, and this document pertains to a physical dental material, the requested information is absent.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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."

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: +82-31-441-2881 Fax: +82-31-441-2883

Contact Name: Myung-Hwan Oh Email: omh@vericom.co.kr

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

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 dentalrestorative material, is aradiopaque, block type,hybrid ceramic that isintended for thefabrication of inlays,onlays, veneers andcrowns. The device canbe matched to thepatient's tooth shadeand is intended for usein dental CAD/CAMmilling procedures.	CERASMART is a pre-cured composite blockfor milling CAD/CAMindirect restorations.The milled device is usedfor the restorations ofboth anterior andposterior teeth.	Descriptionofsubject deviceand predicatedevice is verysimilar; pre-curdcomposite blockfor milling bydentalCAD/CAM
	Indications forUse	Fabrication of inlays,onlays, veneers andcrowns	The product is indicatedfor inlays, onlays,veneers and full crownrestorations, includingcrowns on implants	Both device areused for inlays,onlays, veneersand crowns.
	Design	Pre-cured block	Pre-cured block	Bothdevicesare provided inpre-curd block
	Chemicalcomposition	Resin base	Resin base	Bothdevicesare resin basedcompositeblock.
	Physicalandperformanceproperties	ISO 4049-Compressive strength:534.40 MPa-Flexural Strength:213.30 MPa-Elastic modulus: 10.17GPa-Radio-opacity: 2.4 stepwedge-Vicker'smicrohardness:85.28 HV0.2-Water sorption: 15.51µg/cm2-Solubility: 1.90 µg/cm2	ISO 4049-Compressive strength:501.76 MPa-Flexural Strength:207.91 MPa-Elastic modulus: 9.15GPa-Radio-opacity : 2.6 stepwedge-Vicker'smicrohardness:70.97 HV0.2-Water sorption: 20.67µg/cm3-Solubility : 2.10 µg/cm2	Physicalandperformancepropertiesofthe subjectivedeviceissubstantialequivalenttopredicatedevice.
	Biocompatibility	-Cytotoxicity(Agardiffusion)-Acute systemictoxicity(Oral)	Device is biocompatiblewhen used as directedby dental professionalsper ISO 10993-1.-Acute systemictoxicity(Oral)	Bothdevicesarebiocompatible.
		-Oral mucosa irritation-Sensitization(GPMT)-Genotoxicity(Ames)
	Sterilization	Non-sterile	Non-sterile	Same
	Storagecondition	Avoid exposure to thesunlight.Store at roomtemperature(2-27°C).	Recommended foroptimal performance,store at roomtemperature(4-25°C /39.2-77.0°F) away fromdirect sunlight and highhumidity.	Both devicesarerecommendedat roomtemperatureaway fromsunlight.
	Shelf Life	5 years	5 years	Same
Difference	Shade	30 shades(A1 HT, A2 HT,A3 HT, B1 HT, B2 HT, B3HT, C1 HT, C2 HT, C3 HT,D2 HT, D3 HT, E HT, A1LT, A2 LT, A3 LT, A3.5 LT,A4 LT, B1 LT, B2 LT, B3LT, B4 LT, C1 LT, C2 LT,C3 LT, C4 LT, D2 LT, D3LT, D4 LT, W1 LT, W2 LT)	33 shades(A1 HT, A2 HT,A3 HT, A3.5 HT, A4 HT,B1 HT, B2 HT, B3 HT, B4HT, C1 HT, C2 HT, C3HT, C4 HT, D2 HT, D3 HT,D4 HT, A1 LT, A2 LT, A3LT, A3.5 LT, A4 LT, B1 LT,B2 LT, B3 LT, B4 LT,C1 LT, C2 LT, C3 LT, C4LT, D2 LT, D3 LT, D4 LT,BL)	Shade is anoption that isselectedaccording topatient's teethcolor.
	Size	-Rectangular type:[12]10.212.215,[14L]14.514.518-Disc type:Φ988T/10T/12T/14T,Φ1008T/10T/12T/14T,Φ95*8T/10T/12T/14T	3 sizes(12, 14, 14L)	Size is an optionthat is selectedaccording topatient'sapplicationregion. The disctype of subjectdevice provideseveralrestorations

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.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.