GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets those criteria for the GuttaSil, a root canal filling material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Standard/Test)	Device Performance
Mechanical/Physical	Appearance (ISO 6876:2012)	Conformed to standard
	Weight (ISO 6876:2012)	Conformed to standard
	Packaging (ISO 6876:2012)	Conformed to standard
	Flow (ISO 6876:2012)	Conformed to standard
	Working Time (ISO 6876:2012)	Conformed to standard
	Setting Time (ISO 6876:2012)	Conformed to standard
	Film Thickness (ISO 6876:2012)	Conformed to standard
	Solubility (ISO 6876:2012)	Conformed to standard
	Radio-opacity (ISO 6876:2012)	Conformed to standard
Biocompatibility	Cytotoxicity (ISO 10993-5:2009)	Biocompatible
	Sensitization (ISO 10993-10:2010)	Biocompatible
	Irritation (ISO 10993-10:2010)	Biocompatible
	Systemic Toxicity (ISO 10993-11:2006)	Biocompatible
	Overview (ISO 10993-1:2009)	Biocompatible
Shelf Life	ISO 6876 tests (Appearance, Package, Flow, Setting Time, Solubility) after aging	Conformed to standard for 2 years

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

The document does not explicitly state the sample size used for each specific test within the non-clinical testing. It only generally refers to "the following testing was conducted." The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but it is implied to be laboratory testing conducted by or for Meta Biomed Co., Ltd.

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

This information is not provided in the document. The tests conducted are non-clinical, primarily physical, chemical, and biocompatibility tests based on ISO standards. These types of tests typically do not involve human expert adjudication of results in the way clinical performance studies do.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical performance and biocompatibility tests against quantitative ISO standards, not evaluations requiring human rater adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance and biocompatibility testing. The device is a material for root canal filling, not an AI-assisted diagnostic or treatment planning tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not Applicable. This device is a material (gutta-percha with a sealer) used in a medical procedure, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the ISO 6876:2012 standard for root canal sealing materials.

For the biocompatibility tests, the "ground truth" is adherence to the biocompatibility criteria specified in the relevant ISO 10993 series standards.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical material, not an AI algorithm or model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable, as there is no training set for this type of device.

Summary

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May 29, 2019

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

Re: K190510

Trade/Device Name: GuttaSil Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EKM Dated: February 20, 2019 Received: March 1, 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

for Malvina B Eydelman, M.D. Director 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) K190510

Device Name GuttaSil

Indications for Use (Describe)

GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.

Type of Use (Select one or both, as applicable)

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

Device Information

Trade Name: GuttaSil ●
. Classification Name: resin, root canal filling
Primary Product Code: KIF
. Secondary Product Code: EKM
Panel: Dental
Regulation Number: 21 CFR 872.3820
Device Class: Class II
Date prepared: 05/09/2019

Predicate Devices:

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

Primary Predicate

K032662, GUTTAFLOW manufactured by COLTENE/WHALEDENT GMBH & CO. KG ●
Reference Devices
K042769, ADSEAL ROOT CANAL SEALER manufactured by META BIOMED CO., LTD. ●
K171449, METACEM manufactured by META BIOMED CO., LTD.

Device Description

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

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Indication for Use

GuttaSil is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

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 Appearance, Weight, Packaging, Flow, Working Time, Setting Time, Film Thickness, Solubility, Radio-opacity according to ISO 6876:2012.
Shelf Life test: ISO 6876 tests (appearance, package, flow, setting time, 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, both devices are silicone based and 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.	GuttaFlow
Device Name	GuttaSil	Coltene/Whaledent GMbH & Company KG
510(k) Number	NA	K032662
Classification Name	resin, root canal filling	resin, root canal filling
Product Code	KIF, EKM	KIF, EKM
Regulation Number	21 CFR 872.3820	21 CFR 872.3820
Indications for use	GuttaSil is a material for permanentobturation of root canals after vitalextirpation and after treatment of pulpalgangrene and temporary filling of thecanal.	GuttaFlow is a material for permanentobturation of root canals after vitalextirpation and after treatment of pulpalgangrene and temporary filling of the canal.

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Raw Material	Gutta-percha powderpolydimethylsiloxaneplatinum catalystzirconium dioxidemicro-silver (preservative)colouring.	Gutta-percha powderpolydimethylsiloxaneplatinum catalystzirconium dioxidemicro-silver(preservative)colouring
Principle of Operation	a cold flowable filling system for root canals.	a cold flowable filling system for root canals
Performance StandardConformance	Conformed to ISO 6876	Conformed to ISO 6876
Biocompatibility	Yes	Yes
Delivery Forms	Single Paste	Single Paste
Sterility	Non-sterile	Non-sterile
Shelf Life	2 years	2 years

Conclusion:

Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to the 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.