Pulpdent Maleic Acid Etchants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K932792 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 Maleic Acid Etchants are classified under Material, Tooth Shade, Resin and function as a dental etching solution. These etchants are designed to condition tooth enamel prior to bonding procedures, enhancing adhesion for restorative materials by creating a micro-retentive surface.
Supplied as a single-use dental reagent, the product is intended for use in clinical dental settings. It is regulated under FDA 510(k) clearance (K932792) with a classification of Device Class 2, and its sterility or reusability is not specified in the regulatory data. Storage conditions are not detailed, but compliance with dental practice protocols is implied.
Frequently asked questions
What is the primary purpose of the Pulpdent Maleic Acid Etchants in dental procedures?
The Pulpdent Maleic Acid Etchants are specifically designed to condition tooth enamel before bonding procedures. By creating a micro-retentive surface, they improve adhesion for restorative materials, ensuring a stronger bond during treatments like fillings or other dental restorations.
Are the Pulpdent Maleic Acid Etchants intended for single-use or can they be reused?
The product is explicitly labeled as a single-use dental reagent, meaning each vial or container is meant for one-time clinical use only. The regulatory data does not specify reusability, so adherence to single-use guidelines is recommended.
How should I store the Pulpdent Maleic Acid Etchants, and what are the recommended storage conditions?
The regulatory data does not provide explicit storage conditions, but as a dental reagent, it should be stored according to standard dental practice protocols. This typically includes keeping it in a cool, dry place, away from direct sunlight, and ensuring proper sealing to maintain potency.
What regulatory pathway was followed for the FDA clearance of the Pulpdent Maleic Acid Etchants?
The Pulpdent Maleic Acid Etchants received FDA clearance through a 510(k) submission (K932792) under the Traditional clearance type, reviewed by the Dental (DE) Advisory Committee. The device was determined to be substantially equivalent to a predicate, placing it in Device Class 2.
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 MALEIC ACID ETCHANTS (K932792) — FDA 510(k) | Innolitics, PULPDENT ® Corporation - Advancing Dentistry Together, PULPDENT MALEIC ACID ETCHANTS 510 (k) K932792 - FDA.report, Pulpdent Maleic Acid Etchants - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932792 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K932792 24 fields · synced Sep 18, 2026