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BeautiBond Multi

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110235

by Shofu Dental Corp.

Identifiers

510(k) Number
K110235 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BeautiBond Multi is a resin-based dental adhesive classified as an Agent, Tooth Bonding. It is designed to bond composite restorative materials to enamel and dentin, providing a durable and stable bond for dental restorations. This adhesive utilises a multi-component system to ensure strong adhesion across different tooth surfaces.

BeautiBond Multi is supplied as a single-use, non-sterile system intended for use in dental clinics. It is applied in a thin film (5 µm) and requires a 30-second working time. The device is regulated under FDA 510K clearance (K110235) and falls under the classification of Class II medical devices (regulation number 872.3200). No specific MRI safety information is provided, and the device is not intended for reusable applications.

Frequently asked questions

What is the BeautiBond Multi adhesive used for in dental procedures?

The BeautiBond Multi is a resin-based dental adhesive designed specifically to bond composite restorative materials to both enamel and dentin. This ensures a durable and stable bond, which is essential for long-lasting dental restorations like fillings or crowns.

Is the BeautiBond Multi adhesive single-use or reusable, and how should it be handled?

The BeautiBond Multi is supplied as a single-use system, meaning each package is intended for one application only. Since it is non-sterile, it should be used in a clean dental environment, and any unused portions must be discarded after opening to maintain proper infection control.

How long does the BeautiBond Multi adhesive take to set after application?

The adhesive requires a 30-second working time after application, during which it must be applied in a thin film (5 µm). This ensures proper bonding before the restoration material is placed.

What regulatory pathway was followed for the FDA clearance of the BeautiBond Multi?

The BeautiBond Multi received FDA clearance through a traditional 510(k) process, classified as substantially equivalent to a predicate device. The submission was reviewed by the Dental (DE) Advisory Committee and granted clearance under the product code KLE, falling under FDA regulation number 872.3200 for Class II medical devices.

Are there any specific storage instructions for the BeautiBond Multi adhesive?

While the data does not explicitly detail storage conditions, as a non-sterile, single-use dental adhesive, it should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always follow the manufacturer’s instructions on the packaging for optimal shelf life and performance.

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: BeautiBond® - Shofu USA, BeautiBond - Shofu Dental, BEAUTIBOND - Shofu Dental, BeautiBond Xtreme - Shofu Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA 510(k) K110235 24 fields · synced Sep 20, 2026