4% Acidulated Phosphate Fluoride Etching Gel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K920460 FDA 510(k)
- FDA Product Code
- ELL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3920 FDA 510(k)
- Regulation Number
- 872.3920 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Teeth, Porcelain Etchant (OpenFDA classification) designed to prepare enamel and dentin surfaces for bonding procedures. It contains 4% acidulated phosphate fluoride, which chemically conditions the tooth structure to enhance adhesion of restorative materials, improving durability and seal integrity.
The gel is supplied in single-use syringes (1.2 mL) and is intended for in-office dental use. It is classified as a Class II medical device under FDA regulation 872.3920, with a traditional 510(k) clearance (K920460) for dental applications. No MRI safety or sterility specifications are noted in the regulatory data.
Frequently asked questions
What is the primary purpose of the 4% Acidulated Phosphate Fluoride Etching Gel, and how does it improve dental procedures?
The 4% Acidulated Phosphate Fluoride Etching Gel is designed to chemically condition the enamel and dentin surfaces of teeth, preparing them for bonding with restorative materials. By etching the tooth structure, it enhances adhesion, which improves the durability and seal integrity of dental restorations, ensuring better long-term results.
How is this product supplied, and is it intended for single-use or repeated applications?
The gel is supplied in single-use syringes, each containing 1.2 mL of product. This packaging ensures sterility and convenience for in-office dental procedures, making it ideal for one-time use per patient to maintain hygiene and safety standards.
Does this product require any special storage conditions, and is it compatible with MRI environments?
The provided regulatory data does not specify any special storage conditions for the 4% Acidulated Phosphate Fluoride Etching Gel. Additionally, there is no mention of MRI safety, so it should not be assumed to be MRI-compatible or non-compatible without further confirmation from the manufacturer.
What regulatory pathway was followed for this device, and what does that mean for its use in dental practices?
This device received a traditional 510(k) clearance (K920460) through the FDA’s premarket notification process, demonstrating it is classified as a Class II medical device under regulation 872.3920. This means it has been reviewed by the FDA’s Dental Advisory Committee and deemed substantially equivalent to a predicate device, allowing it to be legally marketed and used in dental offices for its intended purpose.
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, PDF K920460 - 4% Acidulated Phosphate Fluoride Etching Gel, Pulpdent Etch-Rite (Bulk Pack) | Pulpdent Corporation, Etch-Rite - Pulpdent - Prestige Dental Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920460 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K920460 24 fields · synced Sep 18, 2026