Metacem

K171449 · Meta Biomed Co., Ltd. · EMA · May 15, 2018 · Dental

Device Facts

• Record ID: K171449
• Device Name: Metacem
• Applicant: Meta Biomed Co., Ltd.
• Product Code: EMA · Dental
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Metacem is a high-strength, permanent resin cement used by dentists for luting indirect restorations to tooth structure. The device consists of a methacrylate-based paste and a catalyst paste housed in a dual-syringe system. Upon dispensing, the pastes are mixed to form a dual-cured cement that can be self-cured or light-cured, providing versatility for dark, thick, or opaque restorations. The cement is applied to the restoration and tooth surface to provide adhesive bonding. It benefits patients by securing dental restorations, ensuring long-term stability and functional integrity of the tooth structure.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 4049:2009 (film thickness, working/setting time, flexural strength, water sorption/solubility, radio-opacity, color stability) and ISO 11405:2015 (shear bond strength). Biocompatibility verified per ISO 10993 series. Results demonstrate compliance with standards and equivalence to predicate.

Technological Characteristics

Dual-cured resin cement; methacrylate-based (Bis-GMA, TEGDMA, Camphorquinone, DEPT). Dual-syringe delivery. Radio-opaque. Tested per ISO 4049:2009, ISO 11405:2015, and ISO 29022:2013. Shelf life: 2 years.

Indications for Use

Indicated for adhesive cementation of crowns and bridges (ceramic, composite, porcelain, metal), inlays/onlays, porcelain veneers, endodontic posts, and core build-up.

Regulatory Classification

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. 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.

Predicate Devices

• Metacem (K081913)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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: [e-mail] Phone: [phone] Fax: [phone]

## Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

## 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

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.

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# 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:<br>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<br>(34 $μ$ m) |

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