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 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.

AI/ML Overview

This document is a 510(k) clearance letter for a dental composite resin called "Any-Com Flow". It establishes substantial equivalence to a predicate device, "Any-Com". The information provided primarily focuses on the device's technical specifications and a comparison to its predicate, rather than a clinical study evaluating its real-world performance against specific acceptance criteria in a human population.

Therefore, it is impossible to fully answer all aspects of your request as this document does not contain information about:

A study that proves the device meets specific acceptance criteria in a clinical setting with human subjects.
Clinical test set sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, or specific efficacy criteria that would be relevant for devices that provide diagnostic or prognostic outputs.
Training set sample sizes or how their ground truth was established, as this is not an AI/ML device relying on such training.

However, I can extract the acceptance criteria and reported performance based on the non-clinical testing conducted to demonstrate substantial equivalence, which is the focus of this 510(k) application. This non-clinical testing adheres to international standards (ISO 4049 and ISO 10993).

Here's the information extracted and formatted to answer your request as much as possible given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (from ISO 4049, implied)	Reported Device Performance (Any-Com Flow)	Predicate Device Performance (Any-Com)
Curing Depth	Not explicitly stated in the document, but ISO 4049 defines requirements.	2.2 (mm, implied)	1.7-3 (mm, implied)
Water Absorption	Not explicitly stated in the document, but ISO 4049 defines limits.	30	29
Solubility	Not explicitly stated in the document, but ISO 4049 defines limits.	0.6	0.7
Flexural Strength	Not explicitly stated in the document, but ISO 4049 defines minimums.	125	101
Radiopacity	Not explicitly stated in the document, but ISO 4049 defines minimums (e.g., equivalent to aluminum).	1.35	1.60
Biocompatibility	Conformed to ISO 10993 (implied passing all relevant tests)	Yes (conformed to ISO 10993-5, 10, and 11)	Yes
Curing Time (600-1000 mW/㎠)	No explicit criteria, but consistency with predicate is key for SE.	20 sec	20 sec
Curing Time (1000-1200 mW/㎠)	No explicit criteria, but consistency with predicate is key for SE.	10 sec	10 sec
Adherence to ISO 4049	Full conformance to ISO 4049 standard.	Conformed to ISO 4049	Conformed to ISO 4049

Notes on Acceptance Criteria: The document states that the performance tests were conducted "in accordance with ISO 4049" and biocompatibility tests "in accordance with ISO 10993." For a 510(k) submission, the "acceptance criteria" are implied to be that the device successfully meets all relevant requirements and limits defined by these international standards for dental restorative materials and biocompatibility, respectively, and that its performance is substantially equivalent to the predicate device. The exact numerical limits from the ISO standards are not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many specimens were tested for flexural strength). These details would typically be found in the full test reports referenced in the submission, not the summary.
Data Provenance: The tests were conducted by MEDICLUS Co., Ltd., which is based in the Republic of Korea. The testing is non-clinical (laboratory-based) rather than patient-derived data, so there is no "country of origin of the data" in the sense of patient demographics. The tests are "retrospective" in the sense that they were conducted for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The "test set" here refers to physical samples of the dental material, and the "ground truth" is established by direct measurement against known ISO standards and methods, not by expert consensus (e.g., no radiologists or other medical professionals are involved in interpreting results for material properties like flexural strength).

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting complex clinical data or images by multiple experts. For material property testing, results are quantitative measurements against an established standard, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). Any-Com Flow is a dental restorative material, not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. Any-Com Flow is not an algorithm or an AI device. The "performance" refers to the physical and chemical properties of the material itself.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests is based on direct physical and chemical measurements against the specified methodologies and requirements of ISO 4049 (for dental polymer-based restorative materials) and ISO 10993 (for biological evaluation of medical devices). This is akin to established scientific and engineering standards for material properties.

8. The sample size for the training set

This information is not applicable. Any-Com Flow is a dental material, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this device.

Summary

FDA 510(k) Clearance Letter - Any-Com Flow

Page 1

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

Doc ID # 04017.07.05

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.

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K250823 - Priscilla Chung Page 2

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 Page 3

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,

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

Page 4

Indications for Use

Marketing application/submission number	K250823
Device trade name(s)	Any-Com Flow

Indications for Use:

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

Types of uses:
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Any-Com Flow Page 8 of 24
K250823

Page 5

510(k) Summary

K250823

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 : +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
Phone: 714.202.5789 Fax: 714-409-3357
Email: juhee.c@lkconsultinggroup.com

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:

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

Page 6

510(k) summary 2 / 3 page

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	[Syringe image]	[Syringe 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

Page 7

510(k) summary 3 / 3 page

	Subject Device	Predicate Device
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~~1,000㎽/㎠ stand curing unit : 20sec- Curing time of 1,000~~1200 ㎽/㎠ stand curing unit : 10sec	- Curing time of 600~~1,000㎽/㎠ stand curing unit : 20sec- Curing time of 1,000~~1200 ㎽/㎠ stand curing unit : 10sec

Performance Specifications:

	Subject Device	Predicate Device
Curing Depth	2.2	1.7-3
Water Absorption	30	29
Solubility	0.6	0.7
Flexural strength	125	101
Radiopaque	1.35	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 3 / 3 page

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.