This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "White ENDOSEAL MTA," which is a root canal filling material. This submission focuses on non-clinical performance testing and does not involve a study proving the device meets acceptance criteria related to AI/ML or human-in-the-loop performance.

Therefore, most of the requested information regarding AI/ML-specific study design (such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be found in this document.

However, I can extract information related to the performance testing (non-clinical) performed for this device based on the provided text.

Here's the breakdown of the information that can be extracted, and an explanation of why other requested information is not applicable:

Information available from the document:

1. A table of acceptance criteria and the reported device performance

The document lists performance testing against ISO 6876 standards, which implicitly defines acceptance criteria. The reported performance for the proposed device (White ENDOSEAL MTA) is compared to the predicate device.

Performance Metric	Acceptance Criteria (Implicit from ISO 6876)	Reported Device Performance (White ENDOSEAL MTA)	Reported Predicate Device Performance (ENDOSEAL MTA)
Setting time	Conforms to ISO 6876	29 min	12.31 min
Flow	Conforms to ISO 6876	22 mm	21 mm
Radiopacity	Conforms to ISO 6876	7.7 mm	10.14 mm
Film thickness	Conforms to ISO 6876	14 µm	15 µm
Solubility	Conforms to ISO 6876	0.3 %	0.7 %
Capacity, pH	Conforms to internal testing methods	Met preset test criteria	N/A (not explicitly compared in table)
Package, Extraneous matter	Conforms to ISO 6876	Met preset test criteria	N/A (not explicitly compared in table)
Cytotoxicity (MTT)	Conforms to ISO 10993-5	Met preset test criteria	N/A (not explicitly compared in table)
Skin sensitization (GPMT)	Conforms to ISO 10993-10	Met preset test criteria	N/A (not explicitly compared in table)
Acute systemic toxicity	Conforms to ISO 10993-11	Met preset test criteria	N/A (not explicitly compared in table)
Genotoxicity (Mammalian chromosome aberration test & Bacterial Reverse Mutation)	Conforms to ISO 10993-3	Met preset test criteria	N/A (not explicitly compared in table)

Note: The document states "All the test results met the preset test criteria," indicating compliance with the referenced standards (ISO 6876, ISO 10993 series) for the White ENDOSEAL MTA.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified for the non-clinical tests. Non-clinical bench testing often uses small, controlled samples, but the exact number isn't in this summary.
Data Provenance: The testing was conducted by "MARUCHI" (the manufacturer) or by testing institutions following specific ISO standards. The location is the Republic of Korea (manufacturer's address). The data is from non-clinical bench testing, not patient data.

Information NOT available or NOT applicable to this document:

3. 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 document describes non-clinical laboratory testing (e.g., material properties, biocompatibility), not clinical studies involving expert interpretation of medical images or patient outcomes. Therefore, there is no concept of "ground truth" established by medical experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for clinical study ground truth establishment, not non-clinical bench testing.

5. 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

Not applicable. This document is about a root canal filling material, not an AI/ML device for image interpretation or diagnosis. No human reader studies were mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical tests described, the "ground truth" is defined by the objective measurement parameters and specifications set forth by the international standards (ISO 6876, ISO 10993 series) and internal testing methods. There is no clinical "ground truth" derived from patients or expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no AI/ML component or training set.

Summary:

This 510(k) submission for "White ENDOSEAL MTA" focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, confirming it meets established international standards for root canal filling materials. It does not involve AI/ML technology, clinical performance studies, or the types of expert-driven data collection and analysis that would require answering questions 3, 4, 5, 6, 8, and 9.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

March 24, 2021

Maruchi Sung Jang CEO 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, Gangwon-do 26311 REPUBLIC OF KOREA

Re: K202015

Trade/Device Name: White ENDOSEAL MTA Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: January 15, 2021 Received: January 27, 2021

Dear Sung Jang:

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 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 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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4. INDICATION FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
	Indications for Use	See PRA Statement below.
510(k) Number (if known)
K202015
Device Name
White ENDOSEAL MTA
Indications for Use (Describe)
Permanent root canal obturation

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

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PSC Publishing Services (301) 443-6740 EF

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K202015

510(k) Summary

Date: August 20, 2020

1. SUBMITTER

MARUCHI

2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil, Wonju-si, Gangwon-do, 26311, Republic of Korea TEL : +82-33-734-0330

FAX : +82-33-746-2804 Contact Name: Sung Wook, Jang Email: ra@endocem.com

2. DEVICE

·Trade Name: White ENDOSEAL MTA

·Common Name: Root Filling Material

· Classification Name: Resin, Root canal filling

·Regulation Number 872.3820

·Class: 2

·Classification Product Code: KIF

3. PREDICATE DEVICE

K170175, ENDOSEAL MTA, MARUCHI

4. DEVICE DESCRIPTION

This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

5. INDICATIONS FOR USE

Permanent root canal obturation

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6. PERFORMANCE TESTING (NON-CLINICAL)

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

Testing institution's method Capacity, pH •
ISO 6876 - Package, Extraneous matter, Flow, Setting time, Film Thickness, Solubility, Radio-opacity
ISO 10993-5 Cytotoxicity (MTT) •
. ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization (GPMT)
ISO 10993-11 Acute systemic toxicity •
ISO 10993-3 Genotoxicity (Mammalian chromosome aberration test & . Bacterial Reverse Mutation)

	Proposed Device	Predicate Device	Discuss/Justify the Differences
510(k) Number	K202015	K170175	-
Trade Name	White ENDOSEAL MTA	ENDOSEAL MTA	-
Manufacturer	MARUCHI	MARUCHI	-
Common Name	Root Filling Material	Root Filling Material	Equivalent
Classification Name	Resin, Root canal filling	Resin, Root canal filling	Equivalent
Device Class	2	2	Equivalent
Product Code	KIF	KIF	Equivalent
Device Description	This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the	ENDOSEAL MTA is an endodontic sealer based on MTA, providing a root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete	Equivalent
	moisture around the root canal.	filling of the entire root canal including accessory and lateral canals.
Indications for Use	Permanent root canal obturation	* 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.	Equivalent
Intended user	Dental professional	Dental professional	Equivalent
Standards	ISO 6876	ISO 6876	Equivalent
Physical properties	Setting time: 29 minFlow: 22 mmRadiopacity: 7.7 mmFlim thickness: 14 μmSolubility: 0.3 %	Setting time: 12.31 minFlow: 21 mmRadiopacity: 10.14 mmFlim thickness: 15 μmSolubility: 0.7 %	Differences
Chemical Composition	-Zirconium dioxide-Dimethyl sulfoxide-Calcium silicate(Tricalcium silicate)-Water-Bentonite Clay-Polyvinyl alcohol-Polyvinyl pyrrolidone-Lithium Carbonate	-Natural Pure Cement-Zirconium dioxide-Bismuth trioxide-Bentonite Clay-n-Methyl-2-Pyrrolidone-Hypromellose	Differences
Liquid Formula	Paste type	Paste type	Equivalent
Packaging	Pre-loaded syringe	Pre-loaded syringe	Equivalent
Sterile	Non-sterile	Non-sterile	Equivalent
Shelf Life	2 years	2 years	Equivalent

7. SUBSTANITAL EQUIVALENCE

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8. SUBSTANTIAL EQUIVALENCE DISCUSSION

White ENDOSEAL MTA has the same Indications for Use and the principle of operations as the predicate devices. It is intended purpose as they are placed into the root canal as a root filling materials which met the requirement according to ISO 6876. It has similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices.

The chemical compositions might slightly different from the predicate devices, both are used calcium silicate as base material, and additional components are used to improve flowability.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that White ENDOSEAL MTA is substantially equivalent to the predicate devices. Hence, its equivalent is acceptable.

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.