One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.

AI/ML Overview

The provided document is a 510(k) summary for the medical device "One-Fil Putty." This device is a dental root canal sealer. The document describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly present "acceptance criteria" in a separate table format with pass/fail thresholds. Instead, it lists "Performance Tests in accordance with ISO 6876" as the standards against which the device was evaluated. The results for the "One-Fil Putty" are presented within the "Comparison Chart" (Section 8.1) alongside the predicate device's information for some parameters.

Here's a consolidated table of the performance data extracted from the document, with the understanding that the accepted performance is inferred from compliance with the mentioned ISO standards:

Test Item	Acceptance Criteria (Inferred from ISO 6876)	Reported Device Performance (One-Fil Putty)	Predicate Device Performance (BIO-C REPAIR)
Foreign substance	No foreign matter (ISO 6876:2012(E) 5.1)	No foreign matter	-
Volume	(No specific criterion mentioned, likely for control)	1.77%	-
Packaging	No damage or cracks, no mixing of foreign substances, no other harmful defects in use (ISO 6876:2012(E) 6.3)	No damage or cracks, no foreign substances, no harmful defects	-
Setting time	(Standard specified in ISO 6876:2012(E) 5.4, but specific range not stated as acceptance criteria)	53 min	90-120 minutes
Solubility	(Standard specified in ISO 6876:2012(E) 5.6, but specific limit not stated as acceptance criteria)	1.3%	-
Radio-opacity	Radiopacity of >3mm aluminum (ISO 6876:2012(E) 5.7, ISO 13116:2014)	>3mm aluminum	~7 mm Al
pH	(No specific criterion mentioned as acceptance criteria)	12.79	12.5
Biocompatibility	Biocompatible (in accordance with ISO 10993 series)	Biocompatible	Biocompatible
Shelf-Life	(No specific criterion mentioned as acceptance criteria, but duration of predicate is 2 years)	2 years	2 years

Note: The document only provides the performance results for the subject device and in some cases for the predicate. It does not explicitly state the numerical acceptance criteria for many of these tests. Compliance with the cited ISO standards (e.g., ISO 6876) implies that accepted criteria were met. For "Foreign substance" and "Packaging," the description given serves as the implied acceptance criterion. For "Setting time" and "Solubility," specific numerical limits for ISO 6876 are not provided in this document, only the measured values for the subject device.

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

The document does not provide details on the sample sizes used for the non-clinical performance tests (e.g., how many units were tested for setting time, solubility, etc.).
The data provenance (country of origin of the data, retrospective or prospective) is also not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes performance testing of a physical material (dental root canal sealer) against international standards (ISO 6876, ISO 13116, ISO 10993, etc.), not a diagnostic or AI-based device requiring expert ground truth for interpretation.

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

This information is not applicable as the document describes performance testing of a physical material, not a diagnostic study requiring adjudication of interpretations.

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:

This information is not applicable as the device is a physical dental material, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical dental material, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance tests (foreign substance, setting time, solubility, radiopacity, pH, biocompatibility, shelf-life) is established by objective measurements and laboratory tests conducted according to recognized international standards (ISO 6876, ISO 13116, ISO 10993).

8. The sample size for the training set:

This information is not applicable as the device is a physical material and does not involve an algorithm or a training set in the context of AI/machine learning.

9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical material and does not involve an algorithm or 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, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

March 14, 2025

Mediclus Co., Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, California 92612

Re: K243353

Trade/Device Name: One-Fil Putty Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: October 29, 2024 Received: October 29, 2024

Dear Priscilla Chung:

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 (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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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, MChE, RAC, CQIA 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

Submission Number (if known)

K243353

Device Name

One-Fil Putty

Indications for Use (Describe)

1. Furcation or root perforation treatment via canal
1. Furcation or root perforation treatment via surgical
1. Internal reabsorption treatment via canal or surqical
1. External reabsorption treatment
1. Retrofilling in parendodontic surgery
1. Direct and indirect pulp capping
1. Apexification
1. Apexogenesis and Pulpotomy

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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K243353

510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Feb 5, 2025

1. Applicant / Submitter:

MEDICLUS CO., LTD. No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea Tel : +82-43-211-2877 Fax : +82-43-211-2866

Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	One-Fil Putty
Common Name:	Dental root canal sealer
Classification Name:	Resin, Root Canal Filling
Classification:	Class II, 21 CFR 872.3820
Classification Product Code:	KIF

4. Predicate Device:

BIO-C REPAIR (K180185) by MEDICLUS Co., Ltd.

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5. Device Description:

The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.

Indications for Use: 6.

1. Furcation or root perforation treatment via canal
1. Furcation or root perforation treatment via surgical
1. Internal reabsorption treatment via canal or surgical
1. External reabsorption treatment
1. Retrofilling in parendodontic surgery
1. Direct and indirect pulp capping
1. Apexification
1. Apexogenesis and Pulpotomy

Performance Data (Non-Clinical): 7.

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.

" Performance Tests in accordance with ISO 6876 (Foreign substance, Packaging, Setting time, Solubility, Radiopaque)

No	Test Item	Test Standard
1	Foreign substance	ISO 6876:2012(E) 5.1
2	Volume	-
3	Packaging	ISO 6876:2012(E) 6.3
4	Setting time	ISO 6876:2012(E) 5.4
5	Solubility	ISO 6876:2012(E) 5.6
6	Radio-opacity	ISO 6876:2012(E) 5.7ISO 13116:2014
7	Elution, pH Test	-

Volume, pH Test "
" Biocompatibility Tests in accordance with ISO 10993-5, 10, 11
Shelf Life Test .

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Substantial Equivalence 8.

8.1. Comparison Chart

		Subject Device	Predicate Device	Equivalenceevaluation
Manufacturer		MEDICLUS CO., LTD.	Angelus Industria deProdutos OdontologicosS/A	-
Product Name		One-Fil Putty	BIO-C REPAIR	-
510k#		-	K180185	-
Material		- Zirconium oxide 40%- Tricalcium aluminatecompounds 42%- Hydrophilic polymer18% (Thickening agents)	- Zirconium oxide- Calcium silicates- Calcium oxide- Silicon oxide- Iron oxide- Dispersing agent	-
Curing type		Self-Cure(moisture required)	Self-Cure(moisture required)	same
Indications for UseStatement		1. Furcation or rootperforation treatment viacanal2. Furcation or rootperforation treatment viasurgical3. Internal reabsorptiontreatment via canal orsurgical4. External reabsorptiontreatment5. Retrofilling inparendodontic surgery6. Direct and indirect pulpcapping7. Apexification8. Apexogenesis andPulpotomy	1. Furcation or rootperforation treatment viacanal2. Furcation or rootperforation treatment viasurgical3. Internal reabsorptiontreatment via canal orsurgical4. External reabsorptiontreatment5. Retrofilling inparendodontic surgery6. Direct and indirect pulpcapping7. Apexification8. Apexogenesis andPulpotomy	same
	Standard	ISO 6876	ISO 6876	same
	Foreignsubstance	No foreign matter	-	-
	Volume	1.77%	-	-
TechnologicalCharacteristics	Packaging	There was no damage orcracks in the product, themixing of foreignsubstances, or otherharmful defects in use	-	-
	Settingtime	53 min	90-120 minutes	-
	Solubility	1.3%	-	-
	Radio-opacity	Radiopacity of 3mmaluminum More than that	~ 7 mm AI	-

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	12.79	12.5
Biocompatibility	Using ISO 10993 seriesBiocompatible	Using ISO 10993 seriesBiocompatible	same

Sterile	Non-sterile	Non-sterile
Delivery method	Delivery system: SyringeWeigh: 0.5g , 0.25gUnits per Pack: 0.5g x 4,0.25 x 4, 0.25 x 2	Delivery system: SyringeWeigh: 0.5gUnits per Pack: 4Accessories : tips
	Shelf-Life		2 years	2 years

8.2. Substantial Equivalence Discussion

The subject device and the predicate device have intended use and same technological characteristics and are made of similar materials. They have the same range of physical and chemical properties. The subject and predicate devices are packaged in similar materials and use similar methods of application. Any differences in specific components do not raise new issues of safety or efficacy as both devices confirms to ISO 6876 for performance and ISO 10993 for safety to achieve the indications for use.

9. Conclusion:

Based on the information submitted herein, MEDICLUS CO., LTD. concludes that One-Fil Putty is substantially equivalent to the 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.