10% Phosphoric Acid Etching Gel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K920483 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 device is a Dental Etching Gel containing 10% phosphoric acid, classified under product code EBF. It is designed to roughen the enamel and dentin surfaces of teeth, improving adhesion for restorative materials such as composites and other dental restorations by increasing surface area and retention.
The gel is supplied in a single-use, 5 mL syringe (Catalog code EA-5) and is intended for professional dental use. It is applied for 30 seconds, then rinsed off without residue. The device holds an FDA 510K clearance (K920483) under the Dental advisory committee, with a traditional review process. No sterility or MRI safety information is specified in the data.
Frequently asked questions
What is the primary purpose of the 10% Phosphoric Acid Etching Gel in dental procedures?
The 10% Phosphoric Acid Etching Gel is specifically designed to roughen the enamel and dentin surfaces of teeth. This process increases the surface area and retention, which enhances adhesion for restorative materials like composites and other dental fillings.
How is the Phosphoric Acid Etching Gel supplied, and is it intended for single-use?
The gel comes in a single-use, 5 mL syringe (Catalog code EA-5), making it convenient for professional dental applications. The single-use packaging ensures hygiene and prevents cross-contamination between patients.
How long should the Phosphoric Acid Etching Gel be applied to a tooth before rinsing?
According to the manufacturer’s instructions, the gel should be applied to the tooth surface for 30 seconds before rinsing it off. This duration allows sufficient time for the acid to etch the enamel and dentin effectively.
Is there any information provided about the sterility or safety of this product?
The provided data does not specify any details regarding the sterility of the 10% Phosphoric Acid Etching Gel or its safety for MRI procedures. Clinicians should follow standard infection control protocols when using it.
What regulatory pathway was followed for FDA clearance of this product?
The device received FDA clearance through a 510(k) submission (K920483) under the Dental (DE) Advisory Committee, following a traditional review process. It was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE.
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-All™ - PULPDENT, Pulpdent Etch-All Etching Gel, 10% Phosphoric Acid, 5 mL Syringe, Etch-All EA-5 Syringe Etching Gel - Henry Schein Dental, Etch-All Dental Etching Gel - 10% Phosphoric Acid, 5 mL syringe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920483 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K920483 24 fields · synced Sep 18, 2026