(186 days)
No
The summary describes a material composition and delivery system, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is used for permanent sealing of the root canal, which is a restorative rather than therapeutic function.
No
The device is a permanent sealing material for root canals, which is a therapeutic function, not a diagnostic one. Its intended use is to seal, set, and harden.
No
The device description clearly states it is a "calcium silicate composition" contained in a "plastic syringe" with "plunger, disposable tips, and a holder," indicating it is a physical substance and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent sealing of root canal." This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a material used to fill and seal a root canal. This is a treatment, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
Therefore, based on the provided text, this device is a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Permanent sealing of root canal
Product codes
KIF
Device Description
One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription / Hospital
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
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 (Appearance, Volume, Packaging, Flow Setting time, Film thickness, Solubility, Radiopaque)
- pH Test
- Biocompatibility Tests in accordance with ISO 10993-3, 5, 6, 10, 11 and USP 34,151>
- Shelf Life Test
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
January 26, 2024
Mediclus Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612
Re: K232182
Trade/Device Name: One-Fil Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 28, 2023 Received: November 28, 2023
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 (the 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.
1
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.
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 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).
2
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
510(k) Number (if known)
Device Name One-Fil
Indications for Use (Describe)
Permanent sealing of root canal
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K232182 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:
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 |
|---|---|
| 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:
Well-Root™ST (K170950) by VERICOM Co., Ltd.
5
Device Description: 5.
One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
Indications for Use: 6.
Permanent sealing of root canal
7. Performance Data (Non-Clinical):
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 (Appearance, Volume, Packaging, Flow Setting time, Film thickness, Solubility, Radiopaque)
- pH Test
- Biocompatibility Tests in accordance with ISO 10993-3, 5, 6, 10, 11 and USP 34,151> ■
- Shelf Life Test ■
8. Substantial Equivalence
8.1. Comparison Chart
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Trade name | One-Fil | Well-Root™ST |
| Manufacturer | Mediculs Co.,Ltd | VERICOM Co., Ltd. |
| 510K Number | - | K170950 |
| Product Code | KIF | KIF |
| Indications for | ||
| Use | Permanent sealing of root canal | Permanent sealing of root canal |
| Image | Image: One-Fil product packaging | Image: Well-Root product packaging |
| Raw materials | Insoluble, radiopaque material based on a | |
| calcium silicate compound | Insoluble, radiopaque material based on a | |
| calcium aluminosiliate compound |
6
| Principle of
operation | One-Fil is an insoluble, radiopaque
material which sets and hardens with
moisture providing from dentin tubules
during hydration reaction. One-Fil is
packaged in a preloaded syringe and is
supplied with disposable tips. | WellRoot™ ST is an insoluble, radiopaque
material which sets and hardens with
moisture providing from dentin tubules
during hydration reaction. Well-Root™ST
is packaged in a preloaded syringe and is
supplied with disposable tips. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Standards
Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital |
| Delivery form | Single paste | Single paste |
| Sterility | Non-sterile | Non-sterile |
8.2. Substantial Equivalence Discussion
One-Fil has the same intended use as the predicate devices: Well-Root™ST (K170950) by VERICOM Co., Ltd. The indication of the statement of the subject device is more simplified than the predicate devices but it does not contain new indications.
All of the devices confirm to ISO 6876 and are provided non-sterile. Both One-Fil and Well-Root™ ST are premixed ready-to-use injectable white hydraulic cement paste. The differences between One-Fil and Well-Root™ ST are raw materials. However, performance test according to ISO 6876 and biocompatibility tests according to ISO 10993 demonstrate that the difference does not raise a question in safety and effectiveness. We conclude that One-Fil is substantially equivalent to the predicate device.
9. Conclusion:
Based on the information submitted herein, MEDICLUS CO., LTD. concludes that the One-Fil is substantially equivalent to the predicate device.