MAZIC Duro

• K Number: K163346
• Device Name: MAZIC Duro
• Manufacturer: VERICOM CO., LTD.
• Date Cleared: 2017-03-17 ( 108 days)
• Product Code: EBF POW
• Regulation Number: 872.3690

Intended Use

Fabrication of inlays, onlays, veneers and crowns

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.

Predicate Devices

K133824

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biocompatibility of a dental restorative material used in CAD/CAM milling, with no mention of AI or ML.

Therapeutic

No
The device is a dental restorative material used for fabrication, not a device that provides therapy.

Diagnostic

No.
The device is described as a "dental restorative material" intended for "fabrication of inlays, onlays, veneers and crowns", which are treatments, not diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "dental restorative material, is a radiopaque, block type, hybrid ceramic," which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is the "Fabrication of inlays, onlays, veneers and crowns." This describes a process for creating dental restorations, not a test performed on a sample taken from the human body to provide information about a physiological state or disease.
• Device Description: The device is described as a "dental restorative material" and a "block type, hybrid ceramic." This aligns with materials used for dental procedures, not diagnostic testing.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing a biological sample (blood, urine, tissue, etc.)
  • Detecting or measuring specific substances or markers
  • Providing diagnostic information about a patient's health

The information provided clearly indicates that this device is a material used in the fabrication of dental prosthetics, which falls under the category of dental restorative devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

· Fabrication of inlays, onlays, veneers and crowns

Product codes (comma separated list FDA assigned to the subject device)

EBF

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.

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

Dental professionals

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)

Non-clinical performance testing was conducted for MAZIC™ Duro and the predicate device, CERASMART, including compressive strength, flexural strength, elastic modulus, radio-opacity, vicker's micro hardness, water sorption, and solubility. All test results indicated that MAZIC™ Duro is substantially equivalent to CERASMART in terms of physical properties and performance.

Biocompatibility evaluation for MAZIC™ Duro was conducted in accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. The tests included:

• 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 indicated that MAZIC™ Duro is biocompatible and equivalent to its predicate device, CERASMART.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Compressive strength: 534.40 MPa
• Flexural Strength: 213.30 MPa
• Elastic modulus: 10.17 GPa
• Radio-opacity: 2.4 step wedge
• Vicker'smicrohardness: 85.28 HV0.2
• Water sorption: 15.51 µg/cm2
• Solubility: 1.90 µg/cm2

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.

K133824

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

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.

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 [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
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.	CERASMART is a pre-
cured composite block
for milling CAD/CAM
indirect restorations.
The milled device is used
for the restorations of
both anterior and
posterior teeth.	Description
of
subject device
and predicate
device is very
similar; pre-curd
composite block
for milling by
dental
CAD/CAM
	Indications for
Use	Fabrication of inlays,
onlays, veneers and
crowns	The product is indicated
for inlays, onlays,
veneers and full crown
restorations, including
crowns on implants	Both device are
used for inlays,
onlays, veneers
and crowns.
	Design	Pre-cured block	Pre-cured block	Both
devices
are provided in
pre-curd block
	Chemical
composition	Resin base	Resin base	Both
devices
are resin based
composite
block.
	Physical
and
performance
properties	ISO 4049
-Compressive strength:
534.40 MPa
-Flexural Strength:
213.30 MPa
-Elastic modulus: 10.17
GPa
-Radio-opacity: 2.4 step
wedge
-Vicker'smicrohardness:
85.28 HV0.2
-Water sorption: 15.51
µg/cm2
-Solubility: 1.90 µg/cm2	ISO 4049
-Compressive strength:
501.76 MPa
-Flexural Strength:
207.91 MPa
-Elastic modulus: 9.15
GPa
-Radio-opacity : 2.6 step
wedge
-Vicker'smicrohardness:
70.97 HV0.2
-Water sorption: 20.67
µg/cm3
-Solubility : 2.10 µg/cm2	Physical
and
performance
properties
of
the subjective
device
is
substantial
equivalent
to
predicate
device.
	Biocompatibil
ity	-Cytotoxicity(Agar
diffusion)
-Acute systemic
toxicity(Oral)	Device is biocompatible
when used as directed
by dental professionals
per ISO 10993-1.
-Acute systemic
toxicity(Oral)	Both
devices
are
biocompatible.
		-Oral mucosa irritation
-Sensitization(GPMT)
-Genotoxicity(Ames)
	Sterilization	Non-sterile	Non-sterile	Same
	Storage
condition	Avoid exposure to the
sunlight.
Store at room
temperature(2-27°C).	Recommended for
optimal performance,
store at room
temperature(4-25°C /
39.2-77.0°F) away from
direct sunlight and high
humidity.	Both devices
are
recommended
at room
temperature
away from
sunlight.
	Shelf Life	5 years	5 years	Same
Difference	Shade	30 shades(A1 HT, A2 HT,
A3 HT, B1 HT, B2 HT, B3
HT, C1 HT, C2 HT, C3 HT,
D2 HT, D3 HT, E HT, A1
LT, A2 LT, A3 LT, A3.5 LT,
A4 LT, B1 LT, B2 LT, B3
LT, B4 LT, C1 LT, C2 LT,
C3 LT, C4 LT, D2 LT, D3
LT, 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, B4
HT, C1 HT, C2 HT, C3
HT, C4 HT, D2 HT, D3 HT,
D4 HT, A1 LT, A2 LT, A3
LT, A3.5 LT, A4 LT, B1 LT,
B2 LT, B3 LT, B4 LT,
C1 LT, C2 LT, C3 LT, C4
LT, D2 LT, D3 LT, D4 LT,
BL)	Shade is an
option that is
selected
according to
patient's teeth
color.
	Size	-Rectangular type:
[12]10.212.215,
[14L]14.514.518
-Disc type:
Φ98*8T/10T/12T/14T,
Φ100*8T/10T/12T/14T,
Φ95*8T/10T/12T/14T	3 sizes(12, 14, 14L)	Size is an option
that is selected
according to
patient's
application
region. The disc
type of subject
device provide
several
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.