Any-Core

K252465 · Mediclus Co., Ltd. · EBF · Dec 5, 2025 · Dental

Device Facts

• Record ID: K252465
• Device Name: Any-Core
• Applicant: Mediclus Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Dec 5, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Repair material for provisionals Cement for pins and posts Semipermanent restorative material (e.g., in childrens’ teeth)

Device Story

Any-Core is a dual-cured composite resin for core build-up and post cementation. It is supplied in a dual-barrel syringe with an automix tip for direct intraoral application by licensed dentists. The material polymerizes via light-curing or self-curing. It is available in three shades (A3, White, Blue) to provide esthetics and visual contrast during tooth preparation. The device functions as a restorative and cementing agent, aiding in the structural support of teeth. It benefits patients by providing a stable, radiopaque, and biocompatible material for dental repairs and restorations.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 4049, including working time, setting time, flexural strength, color stability, water absorption, solubility, and radiopacity. Biocompatibility testing conducted per ISO 10993-1, including in vitro cytotoxicity (ISO 10993-5), irritation and skin sensitization (ISO 10993-10), and systemic toxicity (ISO 10993-11).

Technological Characteristics

Dual-cured composite resin containing Bis-GMA, EDMAB, glass powder, TMPTMA, CQ, silicon dioxide, benzoyl peroxide, and pigments. Supplied in dual-barrel syringe with automix tip. Complies with ISO 4049 standards for dental resin-based restorative materials. Radiopaque. Prolonged exposure (B) classification.

Indications for Use

Indicated for dental professionals as a repair material for provisionals, cement for pins and posts, and as a semipermanent restorative material, such as in children's teeth.

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

• LuxaCore by DMG USA, Inc (K012307)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 5, 2025

Mediclus Co., Ltd.
Ku Da Hyeon
RA Associate
No.1210, 134, Gongdan-ro, Heungdeok-gu
Cheongju-si, 28576
Republic Of Korea

Re: K252465
Trade/Device Name: Any-Core
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth Shade Resin Material
Regulatory Class: Class II
Product Code: EBF
Dated: August 6, 2025
Received: November 4, 2025

Dear Ku Da Hyeon:

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.

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"

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

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K252465 - Ku Da Hyeon
Page 2

(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-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).

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K252465 - Ku Da Hyeon
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Sincerely,


Bobak
Shirmohammad
di -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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252465 | ? |
| Please provide the device trade name(s). | | ? |
| Any-Core | | |
| Please provide your Indications for Use below. | | ? |
| - Repair material for provisionals
- Cement for pins and posts
- Semipermanent restorative material (e.g., in childrens’ teeth) | | |
| 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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No. 1210, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea
TEL [phone] FAX [phone] e-mail : [e-mail] www.mediclus.co.kr
MDclus MEDICLUS CO., LTD.

# 510(k) Summary (K252465)

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

Date: Dec 05, 2025

## 1. Submitter/Contact Person

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

## 2. U.S Agent

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-Core
- Common Name: Dental core build-up resin
- Classification Name: Tooth Shade Resin Material
- Product Code: EBF
- Classification regulation: 21 CFR 872.3690

## 4. Predicate Device:

LuxaCore by DMG USA, Inc (K012307)

## 5. Description:

Any-Core is a dual-cured composite material intended for use in core build-up procedures and post cementation. The material demonstrates favorable mechanical properties and is formulated for direct intraoral application onto the tooth surface. Polymerization can be

510(k) summary

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No. 1210, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea
TEL [phone] FAX [phone] e-mail : [e-mail] www.mediclus.co.kr
MDclus MEDICLUS CO., LTD.

achieved by light-curing or self-curing, offering flexibility in clinical use.

Any-Core is available in three shades—A3 (tooth-colored), White, and Blue—providing a combination of natural esthetics and visual contrast to aid in material identification during tooth preparation and placement.

The product is supplied in a dual-barrel syringe and used with an automix tip, which enables intraoral dispensing without the need for manual mixing, supporting consistent and efficient delivery.

## 6. Indication for use:

- Repair material for provisionals
- Cement for pins and posts
- Semipermanent restorative material (e.g., in childrens’ teeth)

## 7. Basis for Substantial Equivalence

### 7.1. Comparison Chart

| | Subject Device | Predicate Device | Equivalence evaluation |
| --- | --- | --- | --- |
| Manufacturer | MEDICLUS Co., Ltd. | DMG America | - |
| Product Name | Any-Core | LuxaCore | - |
| 510k# | K252465 | K012307 | - |
| Product Code | EBF | EBF | |
| Material | Bis-GMA, EDMAB, Glass Powder, TMPTMA, CQ, Silicon dioxide, Benzoyl peroxide, Pigment | Barium glass 69%, pyrog. Silica 3% in a Bis-GMA based matrix of dental resins | Similar |
| Curing type | Dual-cure | Dual-cure | Same |
| Indications for Use Statement | 1) Repair material for provisionals
2) Cement for pins and posts
3) Semipermanent restorative material (e.g., in childrens’ teeth) | 1) Luting of abutments to dentures
2) Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
3) Repair material for provisionals
4) Bite registration material
5) Build up material for plastic bite rails (occlusal | Same |

510(k) summary

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No. 1210, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea
TEL [phone] FAX [phone] e-mail : [e-mail] www.mediclus.co.kr
MDclus MEDICLUS CO., LTD.

| | | | individualisation)
6) Cement for pins and posts
7) Semipermanent restorative material (e.g., in childrens’ teeth) | |
| --- | --- | --- | --- | --- |
| Intended User | | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same |
| Technological Characteristics | Standard | ISO 4049 | ISO 4049 | Similar |
| | Working time | Avg 3 min | 1:30 minutes | |
| | Setting time | Avg 7.63 min | 5 min | |
| | Flexural strength | Avg 96.4 MPa | - | |
| | Color and color stability | Matched the reference chart. No visible change observed by all three observers. | - | |
| | Water absorption | Avg 3.04 μg/mm² | 25 μg/mm² | |
| | Solubility | Avg 5.18 μg/mm² | ca. 1g/l/20°C | |
| | Radio-opacity | Showed higher radiopacity than an equivalent thickness of aluminum. | - | |
| Light curing specification | | Wavelength : 465nm
Light Intensity : 1,500 mW/cm² | Wavelength : 450nm
Light Intensity : 600 mW/cm² | Similar |
| Biocompatibility | | Biocompatible | Biocompatible | Same |
| Delivery method | | • Delivery System: Syringe
• Weight: 9g / 4g
• Disposable tip
• Shade: A3, Blue, White | • Delivery System: Syringe
• Weight: 9g
• Disposable tip
• Shade: A3, Blue, White | Similar |
| Period of Use | | Prolonged exposure(B)
(exceed 24 hours but not 30days) | Prolonged exposure(B)
(exceed 24 hours but not 30days) | Same |
| Shelf-Life | | 2 years | 2 years | Same |

## 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.

## 8. Non-Clinical Testing

- Performance Tests including

510(k) summary

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No. 1210, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea
TEL [phone] FAX [phone] e-mail : [e-mail] www.mediclus.co.kr
MDclus MEDICLUS CO., LTD.

- Appearance, Capacity, Packaging, Working time, Curing time, Flexural strength, Color and Color stability, Water absorption, Solubility, Radiopacity in accordance with ISO 4049.
-shear bond strength

- Biocompatibility Tests
- ISO 10993-1 Biological evaluation of medical devise – Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009, test for in vitro cytotoxicity
- ISO 10993-10:2010, tests for irritation and skin sensitization
- ISO 10993-11:2017, tests for systemic toxicity

## 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