K Number

Device Name

Metacem

Manufacturer

Meta Biomed Co., Ltd

Date Cleared

2018-05-15

(363 days)

Product Code

EMA

Regulation Number

872.3275

Intended Use

Adhesive cementation of: - Crown & Bridges (Ceramic, Composite, Porcelain, Metal) - Inlay / Onlay cementation - Bonding for porcelain veneers - Endodontic posts cementation - Core build up

Device Description

Metacem is a high strength, permanent visible light cured (VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bone systems, to adhesively bond and lute indirect restorations to tooth structure. Metacem consists of a methacrylate base paste and catalyst paste which in use are instantly mixed from a dual syringe of form a dual-cured cement. This mixed version of the cement will self-cure or can be light cured, or both. The dual cure is effective for dark shade, thick or opaque cementation.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K081913

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a resin cement used for bonding indirect restorations to tooth structure, which is a restorative function, not a therapeutic one aimed at treating a disease or condition.

Diagnostic

The device description indicates that Metacem is a resin cement used for bonding and luting indirect restorations to tooth structure, which is a therapeutic or restorative function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states that Metacem is a resin cement consisting of a methacrylate base paste and catalyst paste, which are physical substances used for adhesive bonding. This indicates a material-based device, not a software-only device.

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 clearly describes the device as a dental cement for bonding and luting indirect restorations to tooth structure. This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
Device Description: The description details the chemical composition and curing properties of a dental cement, consistent with a material used for bonding within the mouth.
Anatomical Site: The anatomical site is specified as "Tooth structure (dentin/enamel)," which is part of the human body.
Performance Studies: The performance studies focus on the physical and mechanical properties of the cement (film thickness, strength, solubility, bond strength, etc.) and its biocompatibility, all relevant to its use as a dental material within the mouth. There are no mentions of analyzing biological samples or diagnosing conditions.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Adhesive cementation of:

Crown & Bridges (Ceramic, Composite, Porcelain, Metal)
Inlay / Onlay cementation
Bonding for porcelain veneers
Endodontic posts cementation
Core build up

Product codes

EMA

Device Description

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)

Non-clinical Testing:

Biocompatibility Tests according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-10:2010. ISO 10993-11:2006.
Performance tests such as film thickness, working time, Flexular strength, water sorption/solubility, radio-opacity, and color/color stability according to ISO 4049:2009.
Shelf Life tests according to ISO4049:2009.
Shear Bond Strength tests for dentin and enamel according to ISO 11405:2015.

Key Results: The subject device and predicate devices have substantially equivalent indications for use, shelf life, physical and mechanical properties. The flexural strength demonstration showed higher values for the subject device. The biocompatibility test report indicates that the difference in key biocompatible ingredients does not affect substantial equivalence.

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

Film thickness: 26.4 µm
Working time: homogeneous
Setting time: A1: 3min 14sec, A3: 3min 04sec, B2: 3min 57sec, OP: 3min 34sec, TL: 2min 28sec
Flexular strength: 120.5 MPa
Water sorption: 14.0 µg/mm³
Solubility: 0.5 µg/mm³
Radio-opacity: 2.3 mm
Tensile Bond Strength: Enamel: 27.5 MPa, Dentin: 6.1 MPa
Shear Bond Strength: Dentine: 3MPa, Enamel: 15MPa
Shelf life: 2 years

Predicate Device(s)

K081913

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Meta Biomed Co., Ltd % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K171449

Trade/Device Name: Metacem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: February 7, 2018 Received: February 14, 2018

Dear April Lee:

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

May 15, 2018

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

for 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

Indications for Use

510(k) Number (if known) K171449

Device Name Metacem

Indications for Use (Describe) Adhesive cementation of:

· Crown & Bridges (Ceramic, Composite, Porcelain, Metal)
· Inlay / Onlay cementation
· Bonding for porcelain veneers
· Endodontic posts cementation
· Core build up

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

Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ybkyb12@gmail.com Phone: +82-43-230-8959 Fax: +82-43-218-1988

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Metacem
Classification Name: cement, dental
Product Code: EMA ●
Panel: Dental
Regulation Number: 21 CFR 872.3275
Device Class: Class II ●
Date prepared: 05/08/2018 ●

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K081913, Metacem manufactured by Meta Biomed Co., Ltd. ●

General Description

Indication for Use

Adhesive cementation of:

Crown & Bridges (Ceramic, Composite, Porcelain, Metal) ●
Inlay / Onlay cementation .
Bonding for porcelain veneers ●
Endodontic posts cementation ●
Core build up ●

Comparison of technological Characteristics with Predicate Devices:

	Specification	Subject Device	Primary Predicate Device
Manufacturer	-	META BIOMED CO., LTD.	META BIOMED CO., LTD.
Device Name	-	Metacem	Metacem
510(k) Number	-	NA	K081913
Classification Name	-	Dental Cement	Dental Cement
Product Code	-	EMA	EMA
Regulation Number	-	21 CFR 872.3275	21 CFR 872.3275
Indications for Use	-	Adhesive cementation of:
Crown & Bridges (Ceramic, Composite, Porcelain, Metal) Inlay / Onlay cementation Bonding for porcelain veneers Endodontic posts cementation Core build up
Intended Use	-	Metacem is intended for use in the cementing or fixation of restorations and appliances such as inlays, onlays, veneers, crowns, bridges and posts classed by Type 2, Class 3 according to ISO 4049.
General Composition	-	Bis-GMA [Bisphenol A Glycerolate (1glycerol/Phenol)dimethacrylate] TEGDMA [Tri(ethylene glycol)dimethacrylate] Camphorquinone DEPT [2,2'-(P-Tolyimino)diethanol]
Film thickness	ISO 4049:2009	26.4 $μ$ m	0.034 ± 0.006 mm
(34 $μ$ m)

Working time	ISO 4049:2009	homogeneous	2 min 32 sec
Setting time	ISO 4049:2009	A1: 3min 14sec
A3: 3min 04sec
B2: 3min 57sec
OP: 3min 34sec
TL: 2min 28sec	5 min 17 sec
Flexular strength	ISO 4049:2009	120.5 MPa	99 ± 16.1 MPa
Water sorption
solubility	ISO 4049:2009	Water sorption : 14.0 µg/mm³
Solubility : 0.5 µg/mm³	Water sorption : 29.31 ± 6.81 µm/mm³
Solubility : 2.33 ± 1.30 µm/mm³
Radio-opacity	ISO 4049:2009	2.3 mm	2.33 ± 0.34 mm
Color
Color stability	ISO 4049:2009	Consistency	Consistency
Tensile Bond
Strength	ISO 11405	Enamel: 27.5 MPa
Dentin: 6.1 MPa	Enamel: 28.3 MPa
Dentin: 7.6 MPa
Shear Bond Strength	ISO29022:2013	Dentine: 3MPa
Enamel: 15MPa	N/A
Shelf life	-	2 years	2 years

Non-clinical Testing

The subject device was tested to evaluation its safety and effectiveness according to the following standards:

-Biocompatibility Tests according to ISO 10993-1:2009. ISO 10993-5:2009. ISO 10993-10:2010. ISO 10993-11:2006.
-Performance tests such as film thickness, working time, Flexular strength, water sorption/solubility, radio-opacity, and color/color stability according to ISO 4049:2009.
Shelf Life tests according to ISO4049:2009. -
Shear Bond Strength tests for dentin and enamel according to ISO 11405:2015. -

Conclusions

The subject device is similar to the predicate devices in that they are all dual-curing, radio-opaque and self-adhesive resin cements to be used for permanently cementing restorations.

The subject device and the predicate devices has substantially equivalent of indications for use, shelf life, physical and mechanical properties. As depicted above, the flexular strength between the subject device and predicate device demonstrate higher values for the subject device. This difference does not affect the substantial equivalence.

The subject device is different from the predicate devices in that it contains the same key biocompatible ingredients, but in different proportions. The biocompatibility test report supports this difference and it does not affect the substantial equivalence.