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Bisco D/C Core Composite

FDA 510(k)

Class II (US FDA 510(k))

510(k) K930405

by Bisco Inc.

Identifiers

510(k) Number
K930405 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)

The Bisco D/C Core Composite is a Dental Core Build-Up Material (Product Code: EBF), designed as a dual-cured composite for restoring dental structures. It functions as a core build-up material, post-cementation filler, and dentin replacement in restorative dentistry. The material is formulated to provide structural support and esthetic compatibility with conventional and esthetic fixed restorations. Its composition allows for precise application in core build-up procedures, ensuring durability and aesthetic integration with adjacent teeth.

This composite is supplied as a dual-curable system, requiring mixing of a base and catalyst paste in two shades: Natural (C2) and Opaque. It is intended for single-use in clinical settings and is dispensed via a 1:1 syringe system for controlled application. The device holds FDA 510(k) clearance (K930405) under the Dental (DE) Advisory Committee, classified as substantially equivalent to predicate devices. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance, though specific sterility claims are not stated in the regulatory data.

Frequently asked questions

What clinical applications is the Bisco D/C Core Composite intended for in restorative dentistry?

The Bisco D/C Core Composite is specifically designed for core build-up procedures, post-cementation filling, and as a dentin replacement in restorative dentistry. It provides structural support while ensuring aesthetic compatibility with both conventional and esthetic fixed restorations, allowing for seamless integration with adjacent teeth.

How is the Bisco D/C Core Composite supplied, and what are the available shades?

The material comes as a dual-curable system, requiring mixing of a base and catalyst paste in a 1:1 ratio. It is available in two shades: Natural (C2) and Opaque. The system is packaged for single-use and includes a syringe for precise application in clinical settings.

Is the Bisco D/C Core Composite intended for reuse, and how should it be stored?

The Bisco D/C Core Composite is explicitly designed for single-use in clinical settings. Storage and handling must follow the manufacturer’s guidelines to preserve sterility and performance, though the regulatory data does not explicitly state whether it is sterile or non-sterile.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

The Bisco D/C Core Composite received FDA clearance through a 510(k) submission (K930405), classified as substantially equivalent to predicate devices under the Dental (DE) Advisory Committee. This means it was determined to have the same intended use and technological characteristics as legally marketed predicate devices, ensuring compliance with dental restoration standards.

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: BISCO D/C CORE COMPOSITE (K930405) — FDA 510 (k) | Innolitics, Core-Flo™ DC Core Build-Up Composite | BISCO, BISCO D/C CORE COMPOSITE 510 (k) K930405 - FDA.report, Bisco Bis-Core Opaque Core Build-Up Composite

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bisco Inc.
FDA Applicant
Bisco, Inc.

Sources (1)

  • FDA 510(k) K930405 24 fields · synced Sep 20, 2026