One-Fil Putty

K243353 · Mediclus Co., Ltd. · KIF · Mar 14, 2025 · Dental

Device Facts

• Record ID: K243353
• Device Name: One-Fil Putty
• Applicant: Mediclus Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Mar 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Furcation or root perforation treatment via canal 2. Furcation or root perforation treatment via surgical 3. Internal reabsorption treatment via canal or surgical 4. External reabsorption treatment 5. Retrofilling in parendodontic surgery 6. Direct and indirect pulp capping 7. Apexification 8. Apexogenesis and Pulpotomy

Device Story

One-Fil Putty is a permanent root canal filling and repair material; supplied as a premixed white paste in a glass syringe. Material composition includes zirconium oxide, tricalcium aluminate compounds, and hydrophilic polymer thickening agents. Device is used by dentists in clinical settings for endodontic procedures including perforation repair, pulp capping, and apexification. Material is moisture-activated; self-cures upon contact with moisture in the root canal environment. Provides adhesion and workability for sealing root structures. Clinical benefit derived from biocompatible sealing of root canal systems to support healing and prevent reinfection.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 6876:2012(E) including foreign substance, setting time (53 min), solubility (1.3%), and radiopacity (>3mm Al). Biocompatibility confirmed per ISO 10993-5, 10, 11. No clinical data provided.

Technological Characteristics

Composition: 40% zirconium oxide, 42% tricalcium aluminate, 18% hydrophilic polymer. Form factor: premixed paste in glass syringe. Curing: self-cure (moisture-dependent). Performance standards: ISO 6876 (root canal sealing), ISO 10993 (biocompatibility). Non-sterile.

Indications for Use

Indicated for dental patients requiring root canal repair, perforation treatment, reabsorption treatment, retrofilling, pulp capping, apexification, apexogenesis, or pulpotomy.

Regulatory Classification

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.

Predicate Devices

• BIO-C REPAIR (K180185)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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
- 2. Furcation or root perforation treatment via surgical
- 3. Internal reabsorption treatment via canal or surqical
- 4. External reabsorption treatment
- 5. Retrofilling in parendodontic surgery
- 6. Direct and indirect pulp capping
- 7. Apexification
- 8. 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 : [phone] Fax : [phone]

#### Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92620 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 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
- 2. Furcation or root perforation treatment via surgical
- 3. Internal reabsorption treatment via canal or surgical
- 4. External reabsorption treatment
- 5. Retrofilling in parendodontic surgery
- 6. Direct and indirect pulp capping
- 7. Apexification
- 8. 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<br>ISO 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 | Equivalence<br>evaluation |
|----------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | | MEDICLUS CO., LTD. | Angelus Industria de<br>Produtos Odontologicos<br>S/A | - |
| Product Name | | One-Fil Putty | BIO-C REPAIR | - |
| 510k# | | - | K180185 | - |
| Material | | - Zirconium oxide 40%<br>- Tricalcium aluminate<br>compounds 42%<br>- Hydrophilic polymer<br>18% (Thickening agents) | - Zirconium oxide<br>- Calcium silicates<br>- Calcium oxide<br>- Silicon oxide<br>- Iron oxide<br>- Dispersing agent | - |
| Curing type | | Self-Cure<br>(moisture required) | Self-Cure<br>(moisture required) | same |
| Indications for Use<br>Statement | | 1. Furcation or root<br>perforation treatment via<br>canal<br>2. Furcation or root<br>perforation treatment via<br>surgical<br>3. Internal reabsorption<br>treatment via canal or<br>surgical<br>4. External reabsorption<br>treatment<br>5. Retrofilling in<br>parendodontic surgery<br>6. Direct and indirect pulp<br>capping<br>7. Apexification<br>8. Apexogenesis and<br>Pulpotomy | 1. Furcation or root<br>perforation treatment via<br>canal<br>2. Furcation or root<br>perforation treatment via<br>surgical<br>3. Internal reabsorption<br>treatment via canal or<br>surgical<br>4. External reabsorption<br>treatment<br>5. Retrofilling in<br>parendodontic surgery<br>6. Direct and indirect pulp<br>capping<br>7. Apexification<br>8. Apexogenesis and<br>Pulpotomy | same |
| | Standard | ISO 6876 | ISO 6876 | same |
| | Foreign<br>substance | No foreign matter | - | - |
| | Volume | 1.77% | - | - |
| Technological<br>Characteristics | Packaging | There was no damage or<br>cracks in the product, the<br>mixing of foreign<br>substances, or other<br>harmful defects in use | - | - |
| | Setting<br>time | 53 min | 90-120 minutes | - |
| | Solubility | 1.3% | - | - |
| | Radio-<br>opacity | Radiopacity of 3mm<br>aluminum More than that | ~ 7 mm AI | - |

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| | pH | 12.79 | 12.5 | | | |
|------------------|----|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------|---------|--|
| Biocompatibility | | Using ISO 10993 series<br>Biocompatible | Using ISO 10993 series<br>Biocompatible | same | | |
| | | | | | | |
| Sterile | | Non-sterile | Non-sterile | | | |
| Delivery method | | Delivery system: Syringe<br>Weigh: 0.5g , 0.25g<br>Units per Pack: 0.5g x 4,<br>0.25 x 4, 0.25 x 2 | Delivery system: Syringe<br>Weigh: 0.5g<br>Units per Pack: 4<br>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.