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N-Hybride-Composite Lc

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113563

by VOCO GmbH

Identifiers

510(k) Number
K113563 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)

N-HYBRIDE-COMPOSITE LC is a tooth shade resin material used in dental restorative procedures. It functions as a light-cured composite resin for the restoration of teeth.

It is supplied as a dental device and has received FDA 510(k) clearance under K113563. The device is classified under product code EBF and was reviewed by the Dental advisory committee.

Frequently asked questions

What is the N-HYBRIDE-COMPOSITE LC used for in dental procedures?

The N-HYBRIDE-COMPOSITE LC is a light-cured composite resin used for the restoration of teeth in dental restorative procedures, as it functions as a tooth shade resin material designed to repair or restore tooth structure.

How is the N-HYBRIDE-COMPOSITE LC supplied and what regulatory pathway was used for its clearance?

The device is supplied as a dental device and received FDA 510(k) clearance under submission number K113563, indicating it was found substantially equivalent to a legally marketed predicate device through the 510(k) premarket notification process.

What product code and advisory committee were associated with the review of the N-HYBRIDE-COMPOSITE LC?

The device was classified under product code EBF and reviewed by the Dental advisory committee, which is an administrative classification used during the FDA submission process to categorize the device type and guide review, not to define its clinical indication.

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: Nano-Hybrid Composite | VOCO GmbH, N-HYBRIDE-COMPOSITE LC (K113563) — FDA 510 (k) | Innolitics, Composites | VOCO GmbH, N-hybride-composite Lc 510 (k) FDA Premarket Notification K113563 VOCO GMBH, N-hybride composite LC - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (1)

  • FDA 510(k) K113563 24 fields · synced Oct 6, 2026