CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called CeraSeal, a root canal filling resin. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the content, here's an analysis regarding acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be typically seen in an AI/algorithm performance study. Instead, it lists performance tests conducted according to ISO 6876:2012, which is an international standard for root canal sealing materials. The reported device performance is that CeraSeal "conformed" to ISO 6876.

Performance Test Category	Acceptance Criteria (Implicit: Conformance to ISO 6876:2012)	Reported Device Performance
Visual	Conforms to ISO 6876:2012	Conformed
Capacity	Conforms to ISO 6876:2012	Conformed
Package	Conforms to ISO 6876:2012	Conformed
Flow	Conforms to ISO 6876:2012	Conformed
Setting Time	Conforms to ISO 6876:2012	Conformed
Film Thickness	Conforms to ISO 6876:2012	Conformed
Solubility	Conforms to ISO 6876:2012	Conformed
Radio-opacity	Conforms to ISO 6876:2012	Conformed

Additionally, biocompatibility tests were conducted according to ISO 10993 series and a Shelf Life test was performed, confirming conformance.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in the context of a dataset for an AI/algorithm. The tests mentioned (biocompatibility, performance characteristics like flow, setting time, etc.) are laboratory-based and pertain to the physical and chemical properties of the material itself, not to the performance of an AI model on a dataset of patient data. Therefore, this information is not applicable to an AI device.
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)

This information is not applicable. The device is a physical root canal filling material, not an AI/software device that requires expert-established ground truth on a dataset.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable, as there is no test set in the context of AI/algorithm performance requiring adjudication.
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

This information is not applicable. The device is a physical medical material, not an AI system intended to assist human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. The "ground truth" for this device would be its physical and chemical properties as measured against international standards (ISO 6876 for root canal filling materials and ISO 10993 for biocompatibility), rather than a clinical ground truth like pathology or outcomes data for an AI.
The sample size for the training set

This information is not applicable, as there is no AI algorithm with a training set for this device.
How the ground truth for the training set was established

This information is not applicable, as there is no AI algorithm with a training set for this device.

In summary, the provided document is a 510(k) summary for a root canal filling material. It does not describe an AI/software as a medical device (SaMD) and therefore, most of the questions related to AI acceptance criteria and studies are not applicable. The "acceptance criteria" discussed are compliance with international standards for material properties and biocompatibility.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 7, 2019

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

Re: K190503

Trade/Device Name: CeraSeal Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 11, 2019 Received: March 19, 2019

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.

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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.

Srinivas Nandkumar, Ph.D. Assistant 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) K190503

Device Name CeraSeal

Indications for Use (Describe)

· Permanent obturation of the root canal following vital pulp-extirpation

· Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

CeraSeal is suitable for use in the single cone and lateral condensation technique.

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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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 are the words "META" in dark blue above the word "BIOMED" in teal. 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

Tel
+82-43-216-0433

Fax
+82-43-217-1988

META BIOMED CO.LTD.
E-mail

info@meta-biomed.com
http://www.meta-biomed.com

0(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: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983

Official Correspondent

K190503

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: CeraSeal
. Classification Name: resin, root canal filling
Product Code: KIF
Panel: Dental
Regulation Number: 21 CFR 872.3820
Device Class: Class II
Date prepared: 02/20/2019

Predicate Devices:

K080917, iRoot SP manufactured by Innovative BioCeramix Inc.

Device Description

Indication for Use

Permanent obturation of the root canal following vital pulp-extirpation
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings

CeraSeal is suitable for use in the single cone and lateral condensation technique.

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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 shape on the left, with the top half in dark blue and the bottom half in teal. To the right of the tooth shape, the words "META" and "BIOMED" are stacked on top of each other, also in teal. The "META" has a registered trademark symbol next to it.

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

Tel
+82-43-216-0433

Fax
+82-43-217-1988

Non-clinical Testing

The following testing was conducted on our subject device:

. Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
Performance tests such as visual, capacity, package, flow, setting time, film thickness, solubility . and radio-opacity according to ISO 6876:2012.
. Shelf Life test: ISO 6876 tests (extraneous matter, package, flow, setting time, film thickness and Solubility)

Summary of Technological Characteristics:

The subject device and the predicate device have the same intended use and have the similar technological characteristics and are made of similar 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.

The subject device is different from the predicate devices in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate device.

	Subject Device	Predicate Device
Manufacturer	Meta Biomed Co., Ltd.	Innovative BioCeramix, Inc.
Device Name	CeraSeal	iRoot SP
510(k) Number	NA	K080917
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	● Permanent obturation of the root canal following vital pulp-extirpation● Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressingsCeraSeal is suitable for use in the single cone and lateral condensation technique.	● Permanent obturation of the root canal following vital pulp-extirpation● Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressingsiRoot SP is suitable for use in the single cone and lateral condensation technique.

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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 above the A. Below "META" is the text "BIOMED" in teal.

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

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

Tel

info@meta-biomed.com http://www.meta-biomed.com

	Insoluble, radiopaque material based on acalcium silicate compound containing:	Insoluble, radiopaque material based on acalcium silicate compound containing:
	Thickening agent	Thickening agent
Raw Material	Zirconium dioxideCalcium silicates1, 3 Propanediol	Zirconium oxide fillerCalcium silicatesCalcium phosphate monobasicCalcium hydroxide
Principle of Operation	identical	iRoot SP is a convenient premixed ready-to-use injectable white hydraulic cementpaste developed for permanent root canalfilling and sealing applications. iRoot SPis an insoluble, radiopaque materialwhich requires the presence of water toset and harden. iRoot SP is packaged in apre-loaded syringe and is supplied withdisposable tips.
Performance StandardConformance	Conformed to ISO 6876	Conformed to ISO 6876
Biocompatibility	Yes	Yes
Use	Prescription / Hospital	Prescription / Hospital
Delivery Forms	Single Paste	Single Paste
Sterility	Non-sterile	Non-sterile
Shelf Life	2 years	2 years

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.