1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
1. Luting resin crowns, bridges, inlays, onlays and veneers
1. Luting metal or non-metal/fiber posts
1. Luting orthodontic appliances
1. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)

Device Description

The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages as shown below. The brand name, MAZIC® Cem, is specifically for 8.5g.

It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics.

It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental cement (U-Cem™ Premium & MAZIC® Cem). It describes the device, its intended use, and compares its performance to a predicate device (BisCem, K082449) to establish substantial equivalence.

This document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the establishment of ground truth by experts, MRMC studies, or specific acceptance criteria related to classification metrics (e.g., sensitivity, specificity).

Instead, it focuses on the physical and performance properties of a dental cement, a tangible medical device. The "acceptance criteria" in this context refer to the device's ability to meet certain established standards and to demonstrate comparable performance to a legally marketed predicate device.

Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" (which are performance specifications and compliance with standards) and the "reported device performance" from the document.

Overview of "Acceptance Criteria" and Reported Device Performance

For the U-Cem™ Premium & MAZIC® Cem dental cement, the "acceptance criteria" are implied by its compliance with recognized international standards for dental materials and its demonstration of comparable or superior physical properties to a predicate device. The study proves the device meets these criteria through a series of non-clinical performance tests and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

The device is deemed acceptable if its performance parameters meet or exceed those of the predicate device and comply with relevant ISO standards.

Characteristic ("Acceptance Criteria" Basis)	Predicate Device (BisCem) Performance	Subject Device (U-Cem™ Premium / MAZIC® Cem) Performance	Comment / Compliance
Indications for Use	Match	Match	Substantially Equivalent
Principle of Operation	Dual cured	Dual cured	Substantially Equivalent
Working Time	Physically homogeneous & forming thin layer	Physically homogeneous & forming thin layer	Substantially Equivalent
Setting Time	9 m 08 s	2 m 12 s	Both meet ISO 4049 requirement. Subject device is faster, which is not an issue for substantial equivalence.
Compressive Strength	189.15 MPa	236.35 MPa	Subject device has higher strength.
Flexural Strength	101.93 MPa	135.87 MPa	Subject device has higher strength.
Film Thickness	23 µm	11 µm	Subject device has thinner film (generally desirable).
Shear Bond Strength:			Subject device generally superior or comparable.
- Composite - Dentin	7.68 MPa	12.85 MPa	Subject device higher.
- Composite - Enamel	16.32 MPa	19.16 MPa	Subject device higher.
- Glass Ceramic - Lithium disilicate	5.49 MPa	6.21 MPa	Subject device higher.
- Ceramic Aluminum oxide	4.27 MPa	7.28 MPa	Subject device higher.
- Metal	4.38 MPa	12.70 MPa	Subject device higher.
- Zirconia	5.12 MPa	9.05 MPa	Subject device higher.
Fluoride Release	10.02 ppm	2.42 ppm	Difference noted, but sufficient for claims.
Radio-opacity	None	1.45	Subject device has radiopacity.
Solubility	1.53 µg/mm²	0.87 µg/mm²	Subject device has lower solubility (generally desirable).
Polymerization Shrinkage	4.18 %	4.38 %	Comparable.
Chemical Composition	Amorphous silica (filler), Methacrylate based (resin)	Amorphous silica (filler), Methacrylate based (resin)	Substantially Equivalent.
Method of Application	Bonding agent not required	Bonding agent not required	Substantially Equivalent.
Ions Released	Fluoride	Fluoride	Substantially Equivalent.
Standard Conformed	ISO 4049	ISO 4049	Both conform.
Biocompatibility	Yes	Yes	Both biocompatible.
Use	Prescription / Hospital	Prescription / Hospital	Substantially Equivalent.
Delivery System	Dual-syringe (Automix type)	Dual syringe (Automix and Double Dispenser type)	Additional delivery system for subject device, but mixing ratio same.
Storage Condition	2~8°C	2~8°C	Substantially Equivalent.
Shade Options	Translucent, Opaque	Clear, Universal, Opaque	Subject device has more options.

Study Details (Non-Applicable sections are explicitly stated)

Since this is a submission for a dental cement based on physical and chemical properties and comparison to a predicate device, the standard questions relating to AI/ML or diagnostic image analysis are largely not applicable.

2. Sample size used for the test set and the data provenance:

The document implies that various samples of the U-Cem™ Premium & MAZIC® Cem were used for each physical, chemical, and biological test. Specific sample sizes for each test are not provided in this summary.
The data provenance is from non-clinical bench testing and biocompatibility testing. The country of origin for the testing itself is not explicitly stated, but the manufacturer is Vericom Co., Ltd. from the Republic of Korea. The data is prospective in the sense that the tests were specifically performed for this submission to demonstrate substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. Ground truth, in the AI/ML sense, is not established for this device. The "ground truth" for dental cement is its objective physical and chemical properties, measured using standardized laboratory methods (e.g., ISO standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant for subjective human assessments, typically in diagnostic studies. The performance of this device is measured objectively through lab tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This is not relevant for a dental cement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the intrinsic physical and chemical properties of the cement itself, as measured by the non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on objective measurements derived from standardized laboratory testing methods (e.g., ISO standards for dental materials) and direct comparison to the characteristics of a legally marketed predicate device.

8. The sample size for the training set:

Not Applicable. This device is a manufactured product, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established:

Not Applicable. (See point 8)

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 21, 2020

Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine, California 92620

Re: K193260

Trade/Device Name: U-Cem Premium & MAZIC Cem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 21, 2020 Received: July 24, 2020

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.

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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 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 medical devices and radiation-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.

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193260

Device Name

U-Cem™ Premium & MAZIC® Cem

Indications for Use (Describe)

1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
1. Luting resin crowns, bridges, inlays, onlays and veneers
1. Luting metal or non-metal/fiber posts
1. Luting orthodontic appliances
1. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)

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 (K193260)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 16, 2020

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: U-Cem™ Premium & MAZIC® Cem .
Common Name: Luting Cement .
Classification: Dental Cement, Class II (21 CFR 872.3275) .
. Product Code: EMA

4. Predicate Device

BisCem (K082449) by Bisco, Inc.

5. Description:

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It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.

8. Indications for Use

Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and compositeto-metal varieties

1. Luting resin crowns, bridges, inlays, onlays and veneers
1. Luting metal or non-metal/fiber posts
1. Luting orthodontic appliances
1. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)

9. Substantial Equivalence Discussion:

The U-Cem™ Premium/ the MAZIC® Cem has the same intended use and the principle of operation, and also has similar physical properties demonstrating comparable performance specifications to the predicate device: BisCem (K082449) by Bisco, Inc.

The Indications for Use statement of the subject device is similar to that of the predicate device, but it is described in a slightly different way. However, fundamentally the predicate device's indications cover the subject device's claims.

One of the differences is the subject device has an additional delivery system which is the Double Dispenser type. This Double Dispenser has the same mixing ration as the auto mix type so this difference does not raise a question in substantial equivalence.

Another difference is that the subject device has three shades, whereas, the BisCem has two shades, and some raw materials used might be different. However, bench performance and biocompatibility testing performed demonstrates that these differences would not raise a new question in substantial equivalence. For the tests that were performed according to the standards, both devices satisfied the standards' requirements. For the testing that does not have an international standard, the test results of the subject device were substantially equivalent to the predicate device.

The Physical and Performance properties are also very similar except setting time. The subject device shows faster setting time which is 2 minutes and 12 seconds. Both devices meet the ISO 4049 requirement for the setting time, and it does not a raise an issue to support substantial equivalence.

Based on the information provided herein, it is concluded that the U-Cem™ Premium/ the MAZIC® Cem is substantially equivalent to the predicate device.

	Subject Device	Predicate Device
Device Name	U-Cem™ Premium	BisCem
510k #	K193260	K082449
Manufacturer	VERICOM CO., LTD.	Bisco, Inc.

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Indications for use		1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties2. Luting resin crowns, bridges, inlays, onlays and veneers3. Luting metal or non-metal/fiber posts4. Luting orthodontic appliances5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)	1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties2. Luting resin crowns, bridges, inlays, onlays and veneers3. Luting metal or non-metal/fiber posts4. Luting orthodontic appliances5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
Principle of operation		Dual cured	Dual cured
Physical &Performanceproperties	Working Time(at 60sec. aftercompletion ofmixing)	Physically homogeneous and forming the thin layer	Physically homogeneous and forming the thin layer
	Setting time	2 m 12s	9 m 08 s
	Compressive strength	$236.35MPa$	$189.15MPa$
	Flexural strength	$135.87MPa$	$101.93 MPa$
	Film thickness	$11 μm$	$23 μm$
	Shearbondstrength	Composite -Dentin	$12.85MPa$	$7.68MPa$
		Composite -Enamel	$19.16MPa$	$16.32MPa$
		Glass Ceramic -Litium disilicate	$6.21MPa$	$5.49MPa$
		Ceramic Aluminum oxide	$7.28MPa$	$4.27MPa$
		Metal	$12.70MPa$	$4.38MPa$
		Zirconia	$9.05MPa$	$5.12MPa$
	Fluoride release		$2.42 ppm$	$10.02 ppm$
	Radio-opacity		1.45	None
	Solubility		$0.87 µg/mm²$	$1.53µg/mm²$
	Polymerization shrinkage		4.38%	4.18%
ChemicalComposition	Filler		Amorphous silica	Amorphous silica
	Resin composition		Methacrylate based	Methacrylate based
	Method of applicationIons released		Bonding agent not requiredFluoride	Bonding agent not requiredFluoride
Standard Conformed		ISO 4049	ISO 4049
Biocompatibility		Yes	Yes
Use		Prescription / Hospital	Prescription / Hospital
Delivery system		Dual syringe(Base:Catalyst=1:1), Automix and Double Dispenser type	Dual-syringe(Base:Catalyst=1:1), Automix type
Storage condition		2~8°C(at refrigerator temperature)	2~8°C(at refrigerator temperature)

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Physicalproperties	Shade	- Clear- Universal- Opaque	- Translucent- Opaque
------------------------	-------	------------------------------------	---------------------------

10. Performance Tests (Non-clinical)

. Performance Test:
- ISO 4049 Fourth edition 2009-10-01 Dentistry Polymer-based restorative materials
ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements, Annex D.

ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth i structure

Biocompatibility Tests ●
- ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices part 1: evaluation and testing within a risk management process [including: technical corrigendum 1 (2010)]. (Biocompatibility)
- ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Shelf Life Test Performance Tests in accordance with ISO 4049 and ISO 9917-1 .

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 U-Cem™ Premium & MAZIC® Cem is substantially equivalent to the predicate device as described herein in.

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.