ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment.

AI/ML Overview

The provided text is a 510(k) summary for the medical device "ENDOCEM MTA PREMIXED REGULAR," which is a root canal filling material. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study involving AI, human readers, or a test set with ground truth established by experts, as typically seen in submissions for AI-powered diagnostic devices.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the content provided. I can, however, extract information regarding the acceptance criteria for the device itself and the tests performed to meet them.

Here's the information based on the provided text:

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

The document states that "All the test results met the preset test criteria." However, it does not explicitly list the specific acceptance criteria (e.g., "setting time must be between X and Y minutes") or the exact numerical results obtained for each test. It only lists the tests performed and implies that the performance was satisfactory.

Acceptance Criterion	Reported Device Performance
Non-Clinical Performance Testing
Visual	Met preset test criteria (implied)
Volume test	Met preset test criteria (implied)
Setting time	Met preset test criteria (implied). Specifically, the device's setting time is reported as 4.2 minutes, which "met the preset test criteria."
pH	Met preset test criteria (implied)
ISO 6876 Standards
Package	Met preset test criteria (implied)
Extraneous matter	Met preset test criteria (implied)
Solubility	Met preset test criteria (implied)
Radiopacity	Met preset test criteria (implied)
Biocompatibility Testing (ISO 10993 Series)
Cytotoxicity (MTT)	Met preset test criteria (implied)
Guinea Pig Maximization Test for Skin Sensitization (GPMT)	Met preset test criteria (implied)
Acute systemic toxicity	Met preset test criteria (implied)
Genotoxicity (Mammalian chromosome aberration test & Bacterial Reverse Mutation)	Met preset test criteria (implied)

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

This information is not provided in the document. The type of testing performed (bench and biocompatibility) generally does not involve "test sets" in the context of clinical or AI studies, but rather samples of the material for physical, chemical, and biological evaluation.

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 information is not applicable to the provided document, as it describes the testing of a medical material, not a diagnostic device requiring expert interpretation of results for ground truth.

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

This information is not applicable to the provided document.

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

There is no mention of an MRMC study or AI in the provided document.

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

This information is not applicable to the provided document. The device is a root canal filling material, not an algorithm.

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

This information is not applicable in the traditional sense for this type of device submission. For the physical and chemical tests, "ground truth" would be established by the adherence to specified standards (e.g., ISO 6876) and validated testing methodologies. For biocompatibility, "ground truth" is determined by established biological safety endpoints and accepted testing protocols (e.g., ISO 10993).

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device with a training set.

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

This information is not applicable as this is not an AI/machine learning device with a training set.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2023

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

Re: K213757

Trade/Device Name: Endocem MTA Premixed Regular Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: May 20, 2022 Received: May 26, 2022

Dear Sungwook 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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213757

Device Name ENDOCEM MTA PREMIXED REGULAR

Indications for Use (Describe)

The product is used for indirect pulp capping, direct pulp capping, root end filling and Repair of perforation.

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/1 description: The image contains the logo for Maruchi. The logo consists of a stylized flower-like graphic on the left and the word "MARUCHI" in a sans-serif font on the right. The flower graphic is multi-colored, with petals in shades of blue, green, purple, pink, and orange. The word "MARUCHI" is in a dark gray or black color.

510(k) Summary

Date: February 13, 2023

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: ENDOCEM MTA PREMIXED REGULAR ·Common Name: Root Filling Material · Classification Name: Resin, Root canal filling · Regulation Number 872.3820 ·Class: 2 ·Classification Product Code: KIF

3. PREDICATE DEVICE

K082943, iRoot BP Injectable Root Canal Repair Filling Material, Innovative BioCeramix Inc

K102867, iRoot FS, Innovative BioCeramix Inc

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

The product is used for indirect pulp capping, direct pulp capping, root end filling and

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Image /page/4/Picture/0 description: The image contains the logo for Maruchi. The logo consists of a colorful, stylized flower-like design with rounded petals in shades of blue, green, purple, and pink. To the right of the floral design is the word "MARUCHI" in bold, black sans-serif letters. The overall design is clean and modern.

Repair of perforation.

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 Visual, Volume test, Setting time, pH .
ISO 6876 - Package, Extraneous matter, Setting time, Solubility, Radioopacity
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	Reference Device	Discuss/Justify the Differences
510(k) Number	New	K082943	K102867	-
Trade Name	ENDOCEM MTAPREMIXEDREGULAR	iRoot BP InjectableRoot Canal RepairFilling Material	iRoot FS	-
Manufacturer	MARUCHI	InnovativeBioCeramix Inc	InnovativeBioCeramix Inc	-
Common Name	Root FillingMaterial	Root Filling Material	Root Filling Material	Equivalent
ClassificationName	Resin, Root canal filling	Resin, Root canal filling	Resin, Root canal filling	Equivalent
Device Class	2	2	2	Equivalent
Product Code	KIF	KIF	KIF	Equivalent
DeviceDescription	ENDOCEM MTAPREMIXEDREGULAR is aroot canal fillingmaterialconforming to ISO6876, in a pre-loaded syringe thatdoes not requireany pre-mixing andis set by absorbingmoisture from theroot canalenvironment.	iRoot BP InjectableRoot Canal RepairFilling Material(iRoot BP) is aconvenient ready-to-use white hydraulicpremixed injectableBioAggregate pastedeveloped forpermanent root canalrepair and fillingapplications. iRootBP is an insoluble,radiopaque andaluminum-freematerial based on acalcium silicatecomposition, whichrequires the presenceof water to set andharden. iRoot BPdoes not shrinkduring setting anddemonstratesexcellent physicalproperties. iRoot BPis packaged in apreloaded syringeand is supplied withdisposable tips.	iRoot FS Fast SetRoot Repair Material(iRoot FS) is aconvenient ready-to-use fast setting whitehydraulic premixedbioceramic pastedeveloped forpermanent root canalrepair of rootperforation androot canal resorption,and root end filling,apexification andpulp cappingapplications. iRootFS is an insoluble,radiopaque andaluminum-freematerial based on acalcium silicatecomposition, whichrequires the presenceof water to set andharden. iRoot FSdoes not shrinkduring setting anddemonstratesexcellent physicalproperties. iRoot FSis available as a
Indications forUse	The product is usedfor indirect pulpcapping, direct pulpcapping, root endfilling and Repairof perforation.	Repair of RootPerforationRepair of RootResorptionRoot End FillingApexificationPulp Capping	preloaded syringewith disposable tipsand a preloadedcontainer.Repair of RootPerforationRepair of RootResorptionRoot End FillingApexificationPulp Capping	Equivalent
Intended user	Dental professional	Dental professional	Dental professional	Equivalent
Standards	ISO 6876	ISO 6876	ISO 6876	Equivalent
Setting times	4.2 min	Minimum of 2 hours	Approximately 20minutes	Differences
ChemicalComposition	Zirconium dioxideCalcium silicateDMSO(Dimethylsulfoxide)Calcium aluminateCalcium sulfateBentoniteHydroxypropylMethyl CelluloseSilicaLithium carbonateWaterEthanol	Zirconium oxideCalcium silicatesTantalum pentoxideCalcium phosphatemonobasic and filleragents.	Zirconium oxideDicalcium silicateTantalum pentoxideTricalcium silicateCalcium Sulfate andfiller agents	Differences
Liquid Formula	Paste type	Paste type	Paste type	Equivalent
Packaging	Pre-loaded syringe	Pre-loaded syringe	Pre-loaded syringe	Equivalent
Sterile	Non-sterile	Non-sterile	Non-sterile	Equivalent
Shelf Life	2 years	2 years	2 years	Equivalent

7. SUBSTANITAL EQUIVALENCE

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Image /page/5/Picture/0 description: The image shows the Maruchi logo. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in black, sans-serif font on the right. The graphic has petals in shades of blue, green, pink, and yellow.

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Image /page/6/Picture/0 description: The image contains the Maruchi logo. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in a simple, sans-serif font on the right. The flower graphic has multiple petals in different colors, including blue, green, pink, and purple.

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Image /page/7/Picture/0 description: The image shows the logo for Maruchi. The logo consists of a colorful flower-like graphic on the left and the word "MARUCHI" in a sans-serif font on the right. The graphic is made up of several petals in different colors, including blue, green, purple, and pink.

8. SUBSTANTIAL EQUIVALENCE DISCUSSION

ENDOCEM MTA PREMIXED REGULAR has the same Indications for Use and the principle of operations as the predicate device and reference device. 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 ENDOCEM MTA PREMIXED REGULAR 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.