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.

AI/ML Overview

The provided text is a 510(k) summary for a dental restorative material called "Any-Com Bulk." It is a submission to the FDA seeking substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate.

However, the question asks for acceptance criteria and study details related to a device that uses AI (given the questions about multi-reader multi-case studies, ground truth establishment for training, etc.). The provided text describes a tooth shade resin material (a bulk fill flowable restorative), which is a physical material and not an AI-powered device.

Therefore, I cannot extract the requested information because the document does not pertain to an AI device. There are no tables of acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for an AI model.

The document discusses non-clinical tests for a material, such as:

Performance Tests: 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: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Chronic Toxicity, Carcinogenicity (all conforming to ISO 10993 series).

These are typical tests for a dental material, not an AI software device.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 : +82(43)211-2877 FAX : +82(43)211-2866

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Fax: 714-409-3357 Phone: 714.202.5789 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:

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

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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	Equivalenceevaluation
510K#	K242713	K120453
Manufacturer	MEDICLUS Co., Ltd.Any-Com Bulk	3M ESPE
Product Name	Image: Any-Com Bulk	3M Filtek Bulk Fill FlowableRestorativeImage: 3M Filtek Bulk Fill Flowable Restorative
510k#	-	K120453
Product Code	EBF	EBF
Material	Bis-GMAUDMATEDMABa-GlassCamphorquinone• Inorganic filler loading isapproximately 66% by weight• particles size : 0.1~2.0 μm	Bis-GMAUDMABisEMAProcrylat resins• Inorganic filler loading isapproximately 64.5% byweight• Particle size : 0.1 to 5.0 μm	Similar
Curing type	Light Curing	Light Curing	Same
Indications forUse Statement	• Base under Class I and Class IIdirect restorations• Liner under direct restorativematerials• Restoration of small cavities• Class III and V restorations• Core build-ups	• Base under Class I and 11direct restorations• Liner under directrestorative materials• Pit and fissure sealant• Restoration of minimallyinvasive cavitypreparations (including	Same
			small, non stress-bearingocclusal restorations) ClassIII and V restorationsUndercut blockout• Repair of small enameldefects Repair of smalldefects in esthetic indirectrestorations Repair of resinand acrylic temporarymaterials• As a core build-up whereat least half the coronaltooth structure isremaining to providestructural support for thecrown
	Standard	ISO 4049	ISO 4049
TechnologicalCharacteristics	Curing Depth	3.5 mm	4 mm
	Flexuralstrength	100 Mpa	126.5 Mpa
	WaterAbsorption	30 $\mu g/mm^3$	-	Same
	Solubility	0.6 $\mu g/mm^3$	-
	Radiopacity	over-2.9 mm	2.4 mm
	Color andcolor stability	All samples havea matching shadeguide	-
	Sensitivity toambient light	All samples arephysicallyhomogeneous	-
Biocompatibility	Using ISO 10993 seriesBiocompatible		Using ISO 10993 seriesBiocompatible
	• 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 SAFETYASSESSMENT 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.

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.