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Any-Com Bulk

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242713

by MEDICLUS Co., Ltd.

Identifiers

510(k) Number
K242713 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Any-Com Bulk is a Bulk-Fill Flowable Resin (Tooth Shade Resin) designed for dental restorative applications. It is classified under 21 CFR 872.3690 and functions as a base under Class I and II direct restorations, a liner under direct restorative materials, and for small cavity restorations, Class III and V restorations, as well as core build-ups. The material is formulated to provide structural support and aesthetic integration in dental procedures.

This device is supplied as a light-cured resin and is intended for single-use in dental settings. It is sterile upon packaging and must be handled in accordance with standard dental operating protocols. The product is authorized under FDA 510(k) clearance (K242713) and MDD compliance, ensuring adherence to regulatory standards for dental materials. Storage should follow manufacturer guidelines to maintain integrity and performance.

Frequently asked questions

What types of dental restorations can the Any-Com Bulk resin be used for, and how does it differ from traditional filling materials?

The Any-Com Bulk is designed for base applications under Class I and II direct restorations, as well as liners under direct restorative materials, small cavity restorations, Class III and V restorations, and core build-ups. Unlike traditional fillings, it is a flowable resin that provides both structural support and aesthetic integration, making it ideal for scenarios requiring strength while maintaining natural tooth appearance. Its formulation ensures it can be used as a foundational layer or standalone for smaller restorations.

Is the Any-Com Bulk resin single-use, and if so, why is this important for dental practices?

Yes, the Any-Com Bulk resin is intended for single-use only. This design ensures sterility and infection control, as each sealed package is sterile upon opening and eliminates cross-contamination risks between patients. Single-use also simplifies inventory management and reduces the need for reprocessing, aligning with standard dental operating protocols for hygiene and compliance.

How should the Any-Com Bulk resin be stored to maintain its performance and integrity?

The Any-Com Bulk resin must be stored according to the manufacturer’s guidelines to preserve its properties. While the exact conditions aren’t detailed here, typical recommendations for dental resins include protection from moisture, extreme temperatures, and direct sunlight, as well as sealed packaging until use. Improper storage could compromise its flowability, curing characteristics, or sterility, so adherence to the provided instructions is critical.

What regulatory pathways does the Any-Com Bulk resin follow, and what does that mean for its use in dental settings?

The Any-Com Bulk resin is authorized under FDA 510(k) clearance (K242713) and MDD compliance, confirming it meets U.S. and European regulatory standards for dental materials. The 510(k) clearance indicates it is deemed substantially equivalent to a legally marketed predicate device, while MDD compliance ensures it aligns with European dental material directives. Clinicians can rely on these approvals as evidence of safety, performance, and adherence to manufacturing best practices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Any-Com Bulk by MEDICLUS CO., LTD. | FDA 510(k) Summary, Any-Com® Bulk | MEDICLUS, K242713 - Any-Com Bulk | FDA 510 (k) | Mediclus Co., Ltd., Any-Com Bulk (K242713) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
MEDICLUS Co., Ltd.

Sources (2)

  • FDA 510(k) K242713 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026