Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical performance of a root canal filling material, with no mention of AI or ML.

Therapeutic

Yes
The device is described as a "permanent root canal filling repair material" used for various dental treatments such as "Furcation or root perforation treatment," "Internal reabsorption treatment," and "Direct and indirect pulp capping," which are all therapeutic interventions aimed at treating or repairing a medical condition.

Diagnostic

No

The device description and intended uses indicate that One-Fil putty is a permanent root canal filling and repair material, which implies a therapeutic or restorative function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "permanent root canal filling repair material" which is a physical substance (putty) and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's teeth and root canals (e.g., treating furcations, reabsorptions, pulp capping, apexification). These are therapeutic and restorative procedures, not diagnostic tests performed on samples taken from the body.
Device Description: The device is a root canal filling repair material, a substance used to physically fill and repair damaged areas within the tooth. This is a treatment material, not a diagnostic reagent or instrument.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

In summary, the device is a dental material used for treatment, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

KIF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key results from the comparison chart:
Setting time: 53 min
Solubility: 1.3%
Radio-opacity: Radiopacity of 3mm aluminum More than that
pH: 12.79
Biocompatibility: Using ISO 10993 series Biocompatible

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180185

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

2

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

3

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:

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.

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) 5.7
ISO 13116:2014
7	Elution, pH Test	-

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

6

Substantial Equivalence 8.

8.1. Comparison Chart

| | | Subject Device | Predicate Device | Equivalence
evaluation |
|----------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | | MEDICLUS CO., LTD. | Angelus Industria de
Produtos Odontologicos
S/A | - |
| Product Name | | One-Fil Putty | BIO-C REPAIR | - |
| 510k# | | - | K180185 | - |
| Material | | - Zirconium oxide 40%

Tricalcium aluminate
compounds 42%
Hydrophilic polymer
18% (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 Use
Statement | | 1. Furcation or root
perforation treatment via
canal

Furcation or root
perforation treatment via
surgical
Internal reabsorption
treatment via canal or
surgical
External reabsorption
treatment
Retrofilling in
parendodontic surgery
Direct and indirect pulp
capping
Apexification
Apexogenesis and
Pulpotomy | 1. Furcation or root
perforation treatment via
canal
Furcation or root
perforation treatment via
surgical
Internal reabsorption
treatment via canal or
surgical
External reabsorption
treatment
Retrofilling in
parendodontic surgery
Direct and indirect pulp
capping
Apexification
Apexogenesis and
Pulpotomy | same |
| | Standard | ISO 6876 | ISO 6876 | same |
| | Foreign
substance | No foreign matter | - | - |
| | Volume | 1.77% | - | - |
| Technological
Characteristics | Packaging | There was no damage or
cracks in the product, the
mixing of foreign
substances, or other
harmful defects in use | - | - |
| | Setting
time | 53 min | 90-120 minutes | - |
| | Solubility | 1.3% | - | - |
| | Radio-
opacity | Radiopacity of 3mm
aluminum More than that | ~ 7 mm AI | - |

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	pH	12.79	12.5
Biocompatibility		Using ISO 10993 series
Biocompatible	Using ISO 10993 series
Biocompatible	same

Sterile		Non-sterile	Non-sterile
Delivery method		Delivery system: Syringe
Weigh: 0.5g , 0.25g
Units per Pack: 0.5g x 4,
0.25 x 4, 0.25 x 2	Delivery system: Syringe
Weigh: 0.5g
Units per Pack: 4
Accessories : 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.