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2.5% Nitric Acid Etching Gel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920484

by Pulpdent Corporation

Identifiers

510(k) Number
K920484 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 2.5% Nitric Acid Etching Gel is a dental material classified under the product code EBF, designed for etching dental substrates. It is formulated to prepare surfaces for bonding or cementation procedures, improving adhesion and mechanical retention in restorative dentistry.

This gel is supplied as a single-use dental product, intended for use in clinical settings by dental professionals. It has received FDA 510(k) clearance under the Dental (DE) Advisory Committee and is distributed by Pulpdent Corporation. The product is not MRI-safe, and proper handling, storage, and disposal per manufacturer guidelines are required to ensure safety and efficacy.

Frequently asked questions

What is the primary purpose of the 2.5% Nitric Acid Etching Gel in dental procedures?

The 2.5% Nitric Acid Etching Gel is specifically formulated to etch dental substrates, creating a roughened surface that enhances adhesion and mechanical retention. This preparation step is critical before bonding or cementation procedures in restorative dentistry, ensuring better longevity and stability of dental restorations.

Is this product intended for single-use only, and how should it be stored?

Yes, the 2.5% Nitric Acid Etching Gel is designed as a single-use dental product, meaning each application requires a new tube. Since it is intended for clinical use, it should be stored according to the manufacturer’s guidelines to maintain its efficacy and safety. Proper storage conditions help preserve its chemical properties until use.

Can this product be used with any dental restoration material, or are there specific applications it is suited for?

While the gel is designed for etching dental substrates to improve adhesion, its specific compatibility with restoration materials depends on the manufacturer’s instructions for the bonding or cementation system being used. It is primarily intended for preparing surfaces—such as enamel or dentin—for bonding procedures in restorative dentistry, ensuring optimal mechanical retention.

What safety precautions should be taken when handling or disposing of this product?

The 2.5% Nitric Acid Etching Gel is not MRI-safe, so it should not be used in or near MRI environments. Handling requires adherence to standard dental safety protocols, including proper ventilation and personal protective equipment (PPE) to avoid skin or eye contact. Disposal must follow the manufacturer’s guidelines to ensure safe and compliant waste management, as improper disposal could pose environmental or health risks.

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: 2.5% NITRIC ACID ETCHING GEL (K920484) — FDA 510(k) | Innolitics, PDF Porcelain Etch Gel - PULPDENT, PDF EN - Safety Data Sheet, Pulpdent Corporation MATERIAL SAFETY DATA SHEET:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K920484 24 fields · synced Sep 18, 2026