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Brush&Bond Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151518

by Parkell, Inc.

Identifiers

510(k) Number
K151518 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)

Brush&Bond Plus is a dental bonding agent classified as an Agent, Tooth Bonding, Resin. It is designed to create a high‑strength bond between direct or indirect composite restorations and all tooth surfaces, sealing dentinal tubules to reduce sensitivity and protect the pulp from microleakage.

The product is supplied as a self‑etch bonding liquid in a kit format and is cleared under FDA 510(k) as a Class II device. It is applied in three steps, is compatible with light‑cure, self‑cure and dual‑cure resin composites and cements, and is intended for use in both direct and indirect restorative procedures.

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: Brush and Bond, Parkell, Prestige Dental Products, PDF Parkell Brush&Bond sellsheet, Parkell - Brush & Bond Kit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA 510(k) K151518 24 fields · synced Oct 1, 2026