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Pulpdent Semi-Gel Etch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022492

by Pulpdent Corporation

Identifiers

510(k) Number
K022492 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 Pulpdent Semi-Gel Etch is a dental etchant classified as a Phosphoric Acid Etchant (Product Code: EBF). It is a viscous, 35% phosphoric acid solution designed to condition tooth surfaces, including dentin and enamel, as well as glass ionomer cements prior to bonding or restorative procedures. Its semi-gel formulation provides controlled application, particularly favored in orthodontic and restorative dentistry for improved visibility and precision during etching.

This device is supplied as a single-use, non-sterile liquid in a viscous formulation, intended for use in clinical dental settings. It requires no special storage conditions beyond standard dental supply protocols and is regulated under FDA 510(k) clearance (K022492) as a substantially equivalent dental etchant. The product is manufactured by Pulpdent Corporation, Watertown, MA, and adheres to dental industry standards for acid etching in restorative and orthodontic applications.

Frequently asked questions

What types of dental surfaces can the Pulpdent Semi-Gel Etch be used on, and why is its semi-gel formulation beneficial during application?

The Pulpdent Semi-Gel Etch is designed to condition tooth surfaces including both dentin and enamel, as well as glass ionomer cements before bonding or restorative procedures. Its semi-gel formulation provides controlled application, which is particularly useful in orthodontic and restorative dentistry. This viscosity improves visibility and precision during etching, reducing mess and allowing clinicians better control over where the etchant is applied.

Is the Pulpdent Semi-Gel Etch intended for single-use or reusable applications, and what storage requirements does it have?

The Pulpdent Semi-Gel Etch is supplied as a single-use, non-sterile liquid. Since it is non-sterile and intended for clinical use, it does not require special storage conditions beyond standard dental supply protocols. This means it can be stored in a typical dental office setting, following general guidelines for handling dental chemicals.

What is the concentration of phosphoric acid in the Pulpdent Semi-Gel Etch, and how does this compare to traditional liquid etchants?

The Pulpdent Semi-Gel Etch contains a 35% phosphoric acid concentration, which is consistent with many traditional liquid dental etchants. The semi-gel formulation, however, differs from standard liquid etchants by providing a thicker, more viscous consistency. This formulation helps improve application control and visibility, especially in procedures like orthodontics where precision is critical.

How is the regulatory status of the Pulpdent Semi-Gel Etch determined, and what does this mean for clinicians using the product?

The Pulpdent Semi-Gel Etch holds FDA 510(k) clearance (K022492) and is classified as substantially equivalent to a previously cleared dental etchant. This means the product has undergone review by the FDA’s Dental Devices Panel (DE) and was determined to have the same intended use and technological characteristics as a predicate device. Clinicians can rely on this clearance as an indication that the product meets regulatory standards for safety and effectiveness as a phosphoric acid etchant.

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: Etching and Bonding - PULPDENT, Semi-Gel Etchant - PULPDENT, PULPDENT SEMI-GEL ETCH (K022492) — FDA 510 (k) | Innolitics, Semi-Gel Etchant (Pulpdent) | Dental Product | Pearson Dental, Porcelain Etch Gel (Pulpdent) | Dental Product | Pearson Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K022492 24 fields · synced Sep 18, 2026