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14% Hydrofluoric Acid Etching Gel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920482

by Pulpdent Corporation

Identifiers

510(k) Number
K920482 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)

This is a Dental Etching Agent (Product Code: EBF) designed to condition enamel surfaces prior to bonding procedures. It contains 14% hydrofluoric acid, which selectively etches dental enamel to create micro-retentive patterns, improving adhesion of restorative materials such as composites or resins.

The gel is supplied in a single-use format for dental clinical settings and requires careful handling due to its corrosive properties. It is not intended for MRI use and must be stored in a secure, labeled container away from incompatible substances. Authorized for use in the United States under FDA 510(k) clearance (K920482), it adheres to dental regulatory standards for chemical etching agents.

Frequently asked questions

What is the primary purpose of the 14% Hydrofluoric Acid Etching Gel, and how does it improve dental procedures?

The 14% Hydrofluoric Acid Etching Gel is specifically designed to condition dental enamel by creating micro-retentive patterns through selective etching. This process enhances the adhesion of restorative materials like composites or resins, ensuring a stronger bond during bonding procedures. The gel’s chemical action improves the durability and longevity of dental restorations by increasing surface area for better material retention.

Is this product single-use, and why is that important for clinical settings?

Yes, the 14% Hydrofluoric Acid Etching Gel is supplied in a single-use format, which is critical for clinical settings due to its corrosive properties. Single-use packaging minimizes contamination risks, ensures sterility, and reduces the potential for cross-infection between patients. It also simplifies disposal and compliance with infection control protocols in dental offices.

How should this product be stored, and what precautions should be taken given its chemical nature?

The gel must be stored in a secure, labeled container away from incompatible substances to prevent accidental reactions or degradation. Due to its corrosive properties, it should be kept in a cool, dry place, protected from direct sunlight and moisture. Proper labeling ensures safe handling, and storage away from incompatible chemicals (e.g., acids, oxidizers) reduces the risk of hazardous chemical interactions.

What regulatory pathway was followed for FDA clearance, and what does this mean for its use in the U.S.?

The 14% Hydrofluoric Acid Etching Gel received FDA clearance through a 510(k) submission, specifically under the Dental (DE) Advisory Committee and classified as Substantially Equivalent (SE) to a predicate device. This means the product was determined to have the same intended use and technological characteristics as a legally marketed device, ensuring it meets U.S. regulatory standards for dental chemical etching agents. Its clearance (K920482) confirms it adheres to safety and effectiveness requirements for use in 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: 14% HYDROFLUORIC ACID ETCHING GEL - fda.innolitics.com, Boron trifluoride | BF3 | CID 6356 - PubChem, From fundamentals to future directions: A critical review of advanced ..., Substrate treatment processes Patent Grant Hunter , et al. August 19, 2 ...

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) K920482 24 fields · synced Sep 18, 2026