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Etch-Rite Royale

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031915

by Pulpdent Corporation

Identifiers

510(k) Number
K031915 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 Etch-Rite Royale is a dental etching gel containing 37% phosphoric acid, classified as an agent for tooth bonding with resin. It is designed to prepare enamel and dentin surfaces for adhesive bonding procedures in restorative dentistry, ensuring optimal adhesion of resin-based materials.

Supplied as a single-use, non-sterile product, the Etch-Rite Royale is intended for use in dental offices by trained professionals. It is dispensed via a syringe for precise application and features a thixotropic consistency to prevent runoff onto exposed tissue. The product adheres to FDA 510(k) clearance under the classification of Class II medical devices (K031915, KLE).

Frequently asked questions

What is the Etch-Rite Royale used for in dental procedures and how does its thixotropic consistency benefit the user?

The Etch-Rite Royale is a dental etching gel containing 37% phosphoric acid, specifically designed to prepare enamel and dentin surfaces for adhesive bonding with resin-based restorative materials. Its thixotropic consistency prevents runoff onto exposed tissue, ensuring precise application during bonding procedures and minimizing contamination of surrounding areas.

Is the Etch-Rite Royale intended for single-use or can it be reused? How does this affect its handling?

The Etch-Rite Royale is explicitly supplied as a single-use product, meaning each syringe is intended for one application only. This design reduces the risk of cross-contamination and ensures optimal performance, as reuse could compromise sterility and efficacy.

How is the Etch-Rite Royale dispensed, and what practical advantages does this method offer?

The Etch-Rite Royale comes with a built-in syringe for precise, controlled application. This method allows clinicians to apply the gel accurately to the tooth surface, reducing waste and ensuring consistent coverage for optimal bonding results.

What storage requirements should be followed for the Etch-Rite Royale, and why is this important?

The device data does not specify storage conditions, but as a non-sterile product, it should be stored in a clean, dry place away from direct sunlight and extreme temperatures. Proper storage helps maintain the gel’s integrity and effectiveness before use.

What regulatory pathway was followed for FDA clearance of the Etch-Rite Royale, and what does this classification mean for its use?

The Etch-Rite Royale received FDA 510(k) clearance under the classification of Class II medical devices, with a decision code of *SESE* (Substantially Equivalent) and reviewed by the Dental (DE) Advisory Committee. This classification means it is considered low to moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness for its intended use in dental bonding 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: Etch-Rite™ - PULPDENT, Etch-Royale™ - PULPDENT, PDF EN - Safety Data Sheet - Henry Schein

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K031915 24 fields · synced Sep 18, 2026