Pulpdent 2.5% Nitric Acid Etchant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K932793 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 2.5% Nitric Acid Etchant is a dental etchant designed to prepare tooth surfaces for bonding procedures. It functions by creating a micro-etched surface on enamel and dentin, enhancing adhesion of restorative materials such as composites and adhesives.
This device is supplied as a liquid for single-use application in dental settings. It is classified under product code EBF and has received FDA 510(k) clearance (K932793) as substantially equivalent to a predicate device. No additional sterility or MRI safety information is specified in the regulatory data.
Frequently asked questions
What is the primary purpose of the Pulpdent 2.5% Nitric Acid Etchant in dental procedures?
The Pulpdent 2.5% Nitric Acid Etchant is specifically designed to prepare tooth surfaces by creating a micro-etched texture on both enamel and dentin. This micro-etching improves the adhesion of restorative materials like composites and adhesives, ensuring a stronger bond during bonding procedures.
Is the Pulpdent 2.5% Nitric Acid Etchant intended for single-use or repeated applications?
The device is supplied as a liquid for single-use application in dental settings. This means each bottle is meant to be used once and then discarded, ensuring hygiene and preventing cross-contamination.
How is this etchant regulated, and what does its FDA clearance status indicate?
The Pulpdent 2.5% Nitric Acid Etchant received FDA 510(k) clearance (K932793) under the product code EBF, classified as substantially equivalent to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously approved dental etchant, ensuring it meets regulatory safety and effectiveness standards.
Are there any special storage requirements mentioned for this etchant?
The regulatory data does not specify any special storage requirements beyond standard handling for dental liquids. However, since it is a single-use product, it should be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight, to maintain its efficacy until use.
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: PULPDENT 2.5% NITRIC ACID ETCHANT 510(k) K932793 - FDA.report, Pulpdent 2.5% Nitric Acid Etchant - Beudamed, Pulpdent 2.5% Nitric Acid Etchant - allmed.wiki, PDF K932793 - Pulpdent 2.5% Nitric Acid Etchant, Pulpdent-Corp FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932793 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K932793 24 fields · synced Sep 18, 2026