Any-Com Flow

K250823 · Mediclus Co., Ltd. · EBF · Apr 14, 2025 · Dental

Device Facts

• Record ID: K250823
• Device Name: Any-Com Flow
• Applicant: Mediclus Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Apr 14, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

• Anterior and posterior restorations. • Indirect restorations for Inlays, onlays and veneers. Prescription Use (Part 21 CFR 801 Subpart D)

Device Story

Any-Com Flow is a flowable, radiopaque dental composite resin used for anterior and posterior restorations and indirect restorations (inlays, onlays, veneers). The device consists of a methacrylate-based resin matrix with enhanced zirconia fillers. It is supplied in a syringe for manual dispensing by a dentist. After tooth pretreatment, the material is applied to the tooth structure and cured using a standard dental photopolymerizer (light-curing unit). The light-induced polymerization of the methacrylate functionalities bonds the composite to the tooth. The device is intended for professional use in a clinical/hospital setting. It provides a restorative material that matches natural tooth shades, aiding in the functional and aesthetic repair of tooth structure.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing including physical properties (curing depth, water absorption, solubility, flexural strength, radiopacity) per ISO 4049 and biocompatibility testing per ISO 10993-5, 10, and 11.

Technological Characteristics

Methacrylate-based resin matrix with zirconia fillers. Flowable paste form factor. Light-cured via photopolymerizer (600-1200 mW/cm²). Conforms to ISO 4049 for dental restorative materials. Biocompatible per ISO 10993.

Indications for Use

Indicated for anterior and posterior dental restorations, and indirect restorations including inlays, onlays, and veneers.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Any-Com (K241147)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 14, 2025

Mediclus Co., Ltd.
% Priscilla Chung
Regulatory Affairs Consultant
LK Consulting Group USA, Inc.
18881 Von Karman STE 160
Irvine, California 92612

Re: K250823
Trade/Device Name: Any-Com Flow
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth Shade Resin Material
Regulatory Class: Class II
Product Code: EBF
Dated: March 11, 2025
Received: March 18, 2025

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250823 - Priscilla Chung
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250823 - Priscilla Chung
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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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Any-Com Flow
Page 8 of 24

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250823 | ? |
| Please provide the device trade name(s). | | ? |
| Any-Com Flow | | |
| Please provide your Indications for Use below. | | ? |
| • Anterior and posterior restorations.
• Indirect restorations for Inlays, onlays and veneers. | | |
| Please select the types of uses (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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K250823

510(k) Summary

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 3/11/2025

1. Submitter

MEDICLUS Co., Ltd.
No. 1210, 134, Gongdan-ro, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do, Republic of Korea
TEL: [phone] FAX: [phone]

2. U.S Agent/Contact Person

Priscilla Chung
LK Consulting Group USA, Inc.
18881 Von Karman Ave STE 160, Irvine CA 92612
Phone: [phone] Fax: [phone]
Email: [e-mail]

3. Device

- Trade Name: Any-Com Flow
- Common Name: Dental Composite Resin
- Classification Name: Tooth Shade Resin Material
- Product Code: EBF
- Classification regulation: 21 CFR 872.3690

4. Predicate Device:

Any-Com by MEDICLUS Co., Ltd. (K241147)

5. Description:

Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth.

The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and

510(k) summary
1 / 3 page

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darkness that match the patient's natural teeth.

After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.

## 6. Indication for use:

- Anterior and posterior restorations.
- Indirect restorations for Inlays, onlays and veneers.

## 7. Basis for Substantial Equivalence

### 7.1. Comparison Chart

| | Subject Device | Predicate Device |
| --- | --- | --- |
| Trade name | Any-Com Flow | Any-Com |
| Manufacturer | MEDICLUS Co., Ltd. | MEDICLUS Co., Ltd. |
| 510K Number | - | K241147 |
| Product Code | EBF | EBF |
| Indications for Use | • Anterior and posterior restorations
• Indirect restorations for inlays, onlays and veneers. | • Anterior and posterior restorations
• Core build-up
• Indirect restorations for inlays, onlays and veneers. |
| Image | | |
| Raw materials | Methacrylate-based resin matrix, Inorganic fillers etc. | Methacrylate-based resin matrix, Inorganic fillers etc. |
| Principle of operation | When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. | When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. |
| Performance Standards Conformance | Conformed to ISO 4049 | Conformed to ISO 4049 |
| Biocompatibility | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital |

510(k) summary
2 / 3 page

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| Delivery form | Single flowable type | | | Single paste | |
| --- | --- | --- | --- | --- | --- |
| Shade | A1, A2, A3, B1, B2, B3, C2, OWT, OA2, OA3 | | | A1, A2, A3, A3.5, A4, B1, B2, C2, C3, D2, D3, WT, OP, OA2, OA3, TL, A2E, A3E, B2E | |
| Light Curing Specification | - Curing time of 600~1,000mW/cm' stand curing unit : 20sec
- Curing time of 1,000~1200 mW/cm' stand curing unit : 10sec | | | - Curing time of 600~1,000mW/cm' stand curing unit : 20sec
- Curing time of 1,000~1200 mW/cm' stand curing unit : 10sec | |
| Performance Specifications | Curing Depth | 2.2 | | Curing Depth | 1.7-3 |
| | Water Absorption | 30 | | Water Absorption | 29 |
| | Solubility | 0.6 | | Solubility | 0.7 |
| | Flexural strength | 125 | | Flexural strength | 101 |
| | Radiopaque | 1.35 | | Radiopaque | 1.60 |

# 7.2. Substantial Equivalence Discussion

Any-Com Flow is substantially equivalent to a predicate device, Any-Com (K241147), by MEDICLUS Co., Ltd. in terms of indications for use, base raw material, physical properties and technological characteristics. Both Any-Com Flow and Any-Com are ready-to-use paste.

The differences between Any-Com Flow and Any-Com are viscosity. However, performance tests in accordance with ISO 4049 and biocompatibility tests in accordance with ISO 10993 demonstrate that this difference does not raise a question in safety and effectiveness.

Based on the information we provided herein, we conclude that Any-Com is substantially equivalent to the predicate device.

# 8. Non-Clinical Testing

- Performance Tests including Characteristics, Volume, Packing, Sensitivity to ambient light, Depth of Cure, Flexural Strength, Water Absorption, Solubility, Color, Color Stability, Radioactive Impermeable in accordance with ISO 4049.
- Biocompatibility tests in accordance with ISO 10993-5, 10, and 11

# 9. Conclusion

The subject device and the predicate device have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the subject device is substantially equivalent to the predicate device.

510(k) summary