Identifiers
- 510(k) Number
- K920485 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 Etch N Prep is a dental device classified under product code EBF, designed for preparing porcelain surfaces. It is intended for etching and conditioning ceramic substrates to optimize bonding with composites or resin cements, ensuring durable adhesion for restorative procedures.
This device is supplied as a single-use kit and is intended for use in dental offices. It is not sterile but requires proper handling to maintain cleanliness before application. The device was cleared by the FDA under a 510(k) submission (K920485) in 1992, with no specific MRI safety or reusable specifications noted in the data. Storage should follow manufacturer guidelines to preserve efficacy.
Frequently asked questions
What is the Pulpdent Etch N Prep specifically used for in dental procedures?
The Pulpdent Etch N Prep is designed to prepare porcelain surfaces by etching and conditioning ceramic substrates. This process creates a roughened texture that improves adhesion when bonding composites or resin cements, ensuring stronger and more durable restorations during dental procedures.
Is the Pulpdent Etch N Prep intended for single-use or repeated use in a dental office?
The Pulpdent Etch N Prep is supplied as a single-use kit, meaning each package is meant for one application. While it is not sterile, it must be handled cleanly before use to maintain its intended performance.
How should I store the Pulpdent Etch N Prep to keep it effective?
Storage instructions are provided by the manufacturer, but generally, you should follow guidelines that preserve the product’s efficacy. Since no specific storage conditions are detailed in the data, adhering to the manufacturer’s recommendations—likely including protection from contamination and extreme temperatures—will help maintain its intended performance.
What type of regulatory clearance does the Pulpdent Etch N Prep have, and when was it granted?
The Pulpdent Etch N Prep was cleared by the FDA under a 510(k) submission (K920485) in 1992, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This classification falls under product code EBF, which pertains to dental devices for etching or conditioning surfaces.
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: Porcelain Etch Gel - PULPDENT, Porcelain Prep Kit - PULPDENT, Pulpdent Pupldent Etch N Prep - allmed.wiki, PULPDENT Porcelain Prep Kit Instructions - Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920485 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K920485 24 fields · synced Sep 18, 2026