Metapaste Plus

K210904 · Meta Biomed Co., Ltd. · KIF · Jun 30, 2021 · Dental

Device Facts

• Record ID: K210904
• Device Name: Metapaste Plus
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Jun 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.

Device Story

Metapaste Plus is a water-based calcium hydroxide paste for temporary root canal filling. Supplied in a pre-mixed syringe for direct delivery into the root canal. Contains barium sulfate for radiopacity, allowing clinicians to confirm treatment status via X-ray. Material is water-soluble for easy removal. Used by dentists/endodontists in clinical settings. Provides an alkaline environment via calcium hydroxide. Benefits include biocompatibility and ease of application/removal. Clinical decision-making is supported by radiopaque visualization of the filling material.

Clinical Evidence

Bench testing only. Performance testing included flowability and radiopacity per ISO 6876:2012, and biocompatibility testing per ISO 10993 series (parts 1, 3, 5, 6, 10, 11). Shelf life and physical properties (appearance, weight, packaging) were verified against manufacturer standards.

Technological Characteristics

Water-based calcium hydroxide paste. Composition: Calcium hydroxide, barium sulfate, aluminum oxide, titanium oxide, polyethylene glycol, dihydrogen oxide. Delivery: Pre-mixed syringe. Radiopacity: 3.1mm (ISO 6876). Flowability: 21mm (ISO 6876). Non-sterile. Shelf life: 2 years.

Indications for Use

Indicated for temporary root canal filling after endodontic surgery and vital pulpotomy in deciduous teeth. Intended for use by trained healthcare personnel.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• Metapaste (K032605)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

June 30, 2021

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

Re: K210904

Trade/Device Name: Metapaste Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 15, 2021 Received: March 26, 2021

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. 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.

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

{1}------------------------------------------------

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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K210904

Device Name Metapaste Plus

Indications for Use (Describe)

Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth.

Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |

> 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 Drug 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Meta Biomed. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape is the text "META" in dark blue, with a registered trademark symbol above and to the right of the "A". Below "META" is the text "BIOMED" in teal.

Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea

Tel
[phone]

Fax
[phone]

METABIOMED CO.LTD.
E-mail
[e-mail]
http://www.meta-biomed.com

#### 510(k) Summary K210904

#### Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea 28161 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: Metapaste Plus
- Classification Name: Resin, Root Canal Filling .
- Product Code: KIF
- Panel: Dental
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- Date prepared: 03/15/2021

### Predicate Devices:

Primary Predicate

- . K032605, Metapaste by Meta Biomed Co., Ltd.
### Device Description

Metapaste Plus is a water-based calcium hydroxide paste material for root canal temporary filling. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of barium sulfate contained. Also, it is water-soluble and easy to remove.

### Indication for Use

Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery. Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth. Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for META BIOMED. The logo consists of a stylized tooth icon on the left, with the word "META" above the word "BIOMED" on the right. The tooth icon is divided horizontally, with the top half in dark blue and the bottom half in teal. The words "META" and "BIOMED" are also in dark blue and teal, respectively, with a registered trademark symbol next to the word "META".

Address 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea

Tel [phone] Fax [phone]

E-mail
[e-mail] http://www.meta-biomed.com

## Summary of Technological Characteristics:

| | Subject Device | Predicate Device |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Meta Biomed Co., Ltd. | Meta Biomed Co., Ltd. |
| Device Name | Metapaste Plus | Metapaste |
| 510(k) Number | NA | K032605 |
| Classification Name | resin, root canal filling | resin, root canal filling |
| Product Code | KIF | KIF |
| Regulation Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications for use | Metapaste Plus is a biocompatible root<br>canal filling used for the temporary filling<br>of root canals after endodontic surgery.<br>Metapaste Plus can be used on its own<br>and for vital pulpotomy in deciduous<br>teeth.<br>Metapaste Plus is intended for use by<br>qualified healthcare personnel trained in<br>its use. | Metapaste is a biocompatible root canal<br>sealer used for the temporary filling of<br>root canals after endodontic surgery.<br>Metapaste can be used on its own and<br>for vital pulpectomies in deciduous<br>teeth.<br>Metapaste is intended for use by<br>qualified healthcare personnel trained in<br>its use. |
| Raw Material | Calcium hydroxide<br>Barium sulfate<br>Aluminum oxide<br>Titanium oxide<br>Polyethylene glycol<br>Dihydrogen oxide | Calcium hydroxide<br>Barium sulfate<br>Polypropylene glycol |
| Principle of Operation | Metapaste Plus is a biocompatible root<br>canal sealer used for the temporary filling<br>of root canals after endodontic surgery. | Metapaste is a biocompatible root canal<br>sealer used for the temporary filling of<br>root canals after endodontic surgery. |
| Performance Standard<br>Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Flowability | 21mm | 12mm |
| Radio-opacity | 3.1mm | 3.4mm |
| Biocompatibility | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Meta Biomed. The logo consists of a stylized tooth shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape is the text "META" in dark blue, with a registered trademark symbol next to it. Below "META" is the text "BIOMED" in teal. The logo is simple and modern, and the colors are clean and professional.

Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea

tel
82-43-216-0433

fax
82-43-217-1988

**METABIOMED CO.LTD.**

E-mail
[e-mail]

http://www.meta-biomed.com

The subject device and the primary predicate have the similar indications, principle of operation, technological characteristics and materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.

Compared to the primary predicate, Indications for Use, flowability, Radio-opacity and material of the subject device are different.

| 1) Indications for Use | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Metapaste Plus | Metapaste (K032605) | Discussion |
| Metapaste Plus is a<br>biocompatible root canal<br>filling used for the<br>temporary filling of root<br>canals after endodontic<br>surgery. Metapaste Plus<br>can be used on its own and<br>for vital pulpotomy in<br>deciduous teeth.<br>Metapaste Plus is intended<br>for use by qualified<br>healthcare personnel<br>trained in its use | Metapaste is a biocompatible root<br>canal sealer used for the<br>temporary filling of root canals<br>after endodontic surgery.<br>Metapaste can be used on its own<br>and for vital pulpectomies in<br>deciduous teeth.<br>Metapaste is intended for use by<br>qualified healthcare personnel<br>trained in its use | subject device (Metapaste plus) and predicate<br>device (Metapaste) are temporary root canal<br>filling materials. The Indication for Use of subject<br>device (Metapaste Plus) and predicate device<br>(Metapaste) has same contents. In the Metapaste<br>Plus Indication for Use, there is content of<br>pulpotomy that is not found in Indication of use of<br>Metapaste.<br>It is a technique commonly used of temporary root<br>canal fillings and as such does not affect the<br>equivalence of Indication of subject and predicate<br>devices. |

- 2) The flowability between the subject and primary predicate is different; however, the flow of dental root canal filling material shall be more than 17mm in accordance with ISO 6876: 2012 test method, which is the subject device's flowability value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
- 3) The Radio-opacity between the subject and primary predicate is different; however, the Radioopacity of dental root canal filling material shall have a radio opacity equivalent to not less than 3 mm of aluminium in accordance with ISO 6876: 2012 test method, which is the subject device's Radio-opacity value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
- 4) The raw materials of subject device and the predicate device have a little difference in specific components and their composition. However, both products belong to calcium hydroxide paste. demonstrating their clinical safety and the biocompatibility of subject device has been proved by performing tests required for evaluating its biocompatibility in accordance with ISO10993-1. For this reason, although there is difference of raw materials between subject device and predicate device, it does not affect the clinical safety of subject device.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains a logo for Meta Biomed. The logo consists of a stylized tooth icon on the left, with the word "META" above the word "BIOMED" on the right. The tooth icon is split into two colors, with the top half being a dark blue and the bottom half being a teal color. The words "META" and "BIOMED" are also in teal, and there is a registered trademark symbol next to the word "META".

Address
270, Osongsaengmyeong 1-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do,
Korea

[phone] [phone]

Tol

## Non-clinical Testing

The following testing was conducted on our subject device:

- Performance testing of Appearance, Weight, Packaging according to Manufacturer standard. o
- Performance testing of Flowability and Radio-opacity according to ISO 6876:2012.
- . Biocompatibility Tests according to EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-6:2009, EN ISO 10993-10:2013, EN ISO 10993-11:2017.
- Shelf Life test: Manufacturer standard tests (Appearance, Packaging), ISO 6876:2012 tests ● (Flowability, Radio-opacity)

### Conclusion:

Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate device.