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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Metapaste Plus." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, performance specifications, and biocompatibility, rather than clinical efficacy studies involving human readers or AI algorithms.

Therefore, the information required to fully answer your request regarding acceptance criteria, human reader studies, AI performance, and expert ground truth establishment is not available in the provided text. The document describes non-clinical testing only.

However, I can extract what is available regarding the device's performance and the standards it meets.

Device: Metapaste Plus (Root Canal Filling Resin)

Study Focus: Non-clinical (performance testing, biocompatibility, shelf life) to demonstrate substantial equivalence to a predicate device (Metapaste). The study does not involve AI, human readers, or a test set with expert ground truth in the context of diagnostic performance.

1. Table of Acceptance Criteria (from ISO 6876:2012) and Reported Device Performance

Parameter	Acceptance Criteria (from ISO 6876:2012)	Reported Device Performance (Metapaste Plus)
Flowability	Shall be more than 17 mm	21 mm
Radio-opacity	Equivalent to not less than 3 mm of aluminum	3.1 mm

(Note: The document states these are the acceptance criteria from ISO 6876:2012, to which the device conformed.)

2. Sample Size Used for the Test Set and Data Provenance

Given this is non-clinical testing of a material, "test set" here refers to samples of the material itself subjected to physical and chemical tests. The document does not specify the sample sizes of Metapaste Plus used for these non-clinical tests (e.g., how many samples were tested for flowability or radio-opacity).

Data Provenance: The tests were conducted by the manufacturer, Meta Biomed Co., Ltd., based in South Korea. The data is from non-clinical testing on the device material. It is not applicable in terms of retrospective/prospective human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. The ground truth for this device's performance is established by international standards (ISO 6876:2012) for material properties and biocompatibility standards (EN ISO 10993 series). No human experts were involved in defining "ground truth" for diagnostic accuracy or image interpretation, as this is not a diagnostic device and no such study was performed.

4. Adjudication Method for the Test Set

Not Applicable. As no human experts were establishing diagnostic ground truth, there was no need for an adjudication method. The testing involved standardized laboratory procedures.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this is a non-clinical evaluation of a material, not a diagnostic imaging device involving interpretation by human readers, with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an AI-based diagnostic device. Therefore, no standalone algorithm performance study was relevant or conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptance is based on:

International standards for dental root canal filling materials: ISO 6876:2012 (for flowability and radio-opacity).
International standards for biocompatibility: 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.
Manufacturer's internal standards for appearance, weight, and packaging.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no training set in the context of machine learning.

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 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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known)

K210904

Device Name Metapaste Plus

Indications for Use (Describe)

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)

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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
+82-43-216-0433

Fax
+82-43-217-1988

METABIOMED CO.LTD.
E-mail
info@meta-biomed.com
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: ef1459@meta-biomed.com Phone: +82-43-230-8841 Fax: +82-43-217-1983

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: 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

Indication for Use

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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 +82-43-216-0433 Fax +82-43-217-1988

E-mail
info@meta-biomed.com 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 rootcanal filling used for the temporary fillingof root canals after endodontic surgery.Metapaste Plus can be used on its ownand for vital pulpotomy in deciduousteeth.Metapaste Plus is intended for use byqualified healthcare personnel trained inits use.	Metapaste is a biocompatible root canalsealer used for the temporary filling ofroot canals after endodontic surgery.Metapaste can be used on its own andfor vital pulpectomies in deciduousteeth.Metapaste is intended for use byqualified healthcare personnel trained inits use.
Raw Material	Calcium hydroxideBarium sulfateAluminum oxideTitanium oxidePolyethylene glycolDihydrogen oxide	Calcium hydroxideBarium sulfatePolypropylene glycol
Principle of Operation	Metapaste Plus is a biocompatible rootcanal sealer used for the temporary fillingof root canals after endodontic surgery.	Metapaste is a biocompatible root canalsealer used for the temporary filling ofroot canals after endodontic surgery.
Performance StandardConformance	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

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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
info@meta-biomed.com

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 abiocompatible root canalfilling used for thetemporary filling of rootcanals after endodonticsurgery. Metapaste Pluscan be used on its own andfor vital pulpotomy indeciduous teeth.Metapaste Plus is intendedfor use by qualifiedhealthcare personneltrained in its use	Metapaste is a biocompatible rootcanal sealer used for thetemporary filling of root canalsafter endodontic surgery.Metapaste can be used on its ownand for vital pulpectomies indeciduous teeth.Metapaste is intended for use byqualified healthcare personneltrained in its use	subject device (Metapaste plus) and predicatedevice (Metapaste) are temporary root canalfilling materials. The Indication for Use of subjectdevice (Metapaste Plus) and predicate device(Metapaste) has same contents. In the MetapastePlus Indication for Use, there is content ofpulpotomy that is not found in Indication of use ofMetapaste.It is a technique commonly used of temporary rootcanal fillings and as such does not affect theequivalence of Indication of subject and predicatedevices.

1. 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.
1. 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.
1. 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.

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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

+82-43-216-0433 +82-43-217-1988

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.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.