Any-Com Bulk

• K Number: K242713
• Device Name: Any-Com Bulk
• Manufacturer: MEDICLUS CO., LTD.
• Date Cleared: 2025-02-07 ( 151 days)
• Product Code: EBF
• Regulation Number: 872.3690

Intended Use

- Base under Class I and Class II direct restorations - Liner under direct restorative materials - Restoration of small cavities - Class III and V restorations - Core build-ups

Device Description

Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment. The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

Predicate Devices

K120453

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material properties and application technique of a dental restorative material, with no mention of AI or ML.

Therapeutic

No
The device is a restorative material used for filling cavities and core build-ups, not for treating or preventing a disease or condition. Its function is to restore the structure of teeth.

Diagnostic

No
The device is a restorative material used for filling cavities and core build-ups, which is a treatment, not a diagnostic, function.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a "light cured, radiopaque, flowable restorative material," which is a physical substance, not software. The performance studies also focus on material properties.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The intended uses listed are all related to direct dental restorations and procedures performed on the patient's teeth (e.g., filling cavities, core build-ups). These are clinical procedures, not diagnostic tests performed on samples in vitro (outside the body).
• Device Description: The description details a light-cured, radiopaque, flowable restorative material used for filling and restoring teeth. This aligns with a dental restorative material, not a diagnostic device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.

Therefore, this device falls under the category of a dental restorative material used for treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• Base under Class I and Class II direct restorations
• Liner under direct restorative materials
• Restoration of small cavities
• Class III and V restorations
• Core build-ups

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

EBF

Device Description

Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment.

The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth.

After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

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)

• Performance Tests including Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Flexural Strength, Water Sorption/Solubility, Color and Color stability, Radiopacity in accordance with ISO 4049
• Biocompatibility Tests

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

Curing Depth: 3.5 mm (Subject Device), 4 mm (Predicate Device)
Flexural strength: 100 Mpa (Subject Device), 126.5 Mpa (Predicate Device)
Water Absorption: 30 micrograms/mm^3 (Subject Device)
Solubility: 0.6 micrograms/mm^3 (Subject Device)
Radiopacity: over-2.9 mm (Subject Device), 2.4 mm (Predicate Device)
Color and color stability: All samples have a matching shade guide (Subject Device)
Sensitivity to ambient light: All samples are physically homogeneous (Subject Device)

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.

K120453

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

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

February 7, 2025

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

Re: K242713

Trade/Device Name: Any-Com Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 8, 2025 Received: January 8, 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.

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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,

Bobak
Shirmohammadi -S

For Michael E. Adjodha, M.ChE., 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)

K242713

Device Name

Any-Com Bulk

Indications for Use (Describe)

• Base under Class I and Class II direct restorations
• Liner under direct restorative materials
• Restoration of small cavities
• Class III and V restorations
• Core build-ups

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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510(k) Summary (K242713)

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

Date: 1/7/2025

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 Fax: [phone] Phone: [phone] Email: juhee.c(@lkconsultinggroup.com

3. Device

• Trade Name: Any-Com Bulk
• Common Name: Tooth Shade Resin
• Classification Name: Tooth Shade Resin Material ●
• Product Code: EBF ●
• Classification regulation: 21 CFR 872.3690

4. Predicate Device:

3M Filtek Bulk Fill Flowable Restorative by 3M ESPE (K120453) (Primary predicate)

5. Description:

Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment.

The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the

5

patient's natural teeth.

After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

6. Indication for use:

• Base under Class I and Class II direct restorations
• Liner under direct restorative materials
• " Restoration of small cavities
• . Class III and V restorations
• . Core build-ups

7. Basis for Substantial Equivalence

| | Subject Device | Predicate Device | Equivalence
evaluation | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 510K# | K242713 | K120453 | | |
| Manufacturer | MEDICLUS Co., Ltd.
Any-Com Bulk | 3M ESPE | | |
| Product Name | Image: Any-Com Bulk | 3M Filtek Bulk Fill Flowable
Restorative
Image: 3M Filtek Bulk Fill Flowable Restorative | | |
| 510k# | - | K120453 | | |
| Product Code | EBF | EBF | | |
| Material | Bis-GMA
UDMA
TEDMA
Ba-Glass
Camphorquinone
• Inorganic filler loading is
approximately 66% by weight
• particles size : 0.1~2.0 μm | Bis-GMA
UDMA
BisEMA
Procrylat resins
• Inorganic filler loading is
approximately 64.5% by
weight
• Particle size : 0.1 to 5.0 μm | Similar | |
| Curing type | Light Curing | Light Curing | Same | |
| Indications for
Use Statement | • Base under Class I and Class II
direct restorations
• Liner under direct restorative
materials
• Restoration of small cavities
• Class III and V restorations
• Core build-ups | • Base under Class I and 11
direct restorations
• Liner under direct
restorative materials
• Pit and fissure sealant
• Restoration of minimally
invasive cavity
preparations (including | Same | |
| | | | small, non stress-bearing
occlusal restorations) Class
III and V restorations
Undercut blockout
• Repair of small enamel
defects Repair of small
defects in esthetic indirect
restorations Repair of resin
and acrylic temporary
materials
• As a core build-up where
at least half the coronal
tooth structure is
remaining to provide
structural support for the
crown | |
| | Standard | ISO 4049 | ISO 4049 | |
| Technological
Characteristics | Curing Depth | 3.5 mm | 4 mm | |
| | Flexural
strength | 100 Mpa | 126.5 Mpa | |
| | Water
Absorption | 30 $\mu g/mm^3$ | - | Same |
| | Solubility | 0.6 $\mu g/mm^3$ | - | |
| | Radiopacity | over-2.9 mm | 2.4 mm | |
| | Color and
color stability | All samples have
a matching shade
guide | - | |
| | Sensitivity to
ambient light | All samples are
physically
homogeneous | - | |
| Biocompatibility | Using ISO 10993 series
Biocompatible | | Using ISO 10993 series
Biocompatible | |
| | • Delivery System: Syringe | | • Delivery System: Syringe | |
| | • Weight: 2g | | • Weight: 2g | |
| Delivery method | • Units per Pack: 1, 2, 3 | | • Units per Pack: 2 | |
| | • Accessories: Tip | | • Accessories: Tip | |
| Shade | A1, A2, A3, Blue, TL | | A1, A2, A3, Universal | Same |
| Shelf-Life | 3 years | | 3 years | Same |

7.1. Comparison Chart

510(k) summary

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7.2. Comparison Chart

The subject device has the same indications for use and the technological characteristics as the predicate device. The minor raw materials are different between the devices but the performance and the biocompatibility test results show that it does not raise a concern in safety and effectiveness.

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8. Non-Clinical Testing

• Performance Tests including Appearance, Weight, Packaging, Sensitivity to Ambient ● Light, Curing Depth, Flexural Strength, Water Sorption/Solubility, Color and Color stability, Radiopacity in accordance with ISO 4049
• . Biocompatibility Tests

No	Test Item	Test Standard
1	Cytotoxicity	ISO 10993-5
2	Sensitization	ISO 10993-10
3	Irritation or Intracutaneous Reactivity	ISO 10993-10
4	Acute Systemic Toxicity	ISO 10993-11
5	Material-Mediated Pyrogenicity
6	Subacute/Subchronic Toxicity
7	Genotoxicity
8	Implantation	BIOLOGICAL SAFETY
ASSESSMENT REPORT
9	Chronic Toxicity
10	Carcinogenicity

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.