Pulpdent Cavity Preparation Ii, Pulpdent Cavity Preparation Ii Wuth Fluoride
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994181 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Cavity Preparation II is a dental cavity varnish designed to protect and condition the dentin during tooth preparation for restorative procedures. It contains chlorhexidine gluconate, with a fluoride-stabilized variant available for additional remineralization support.
This solution is intended for single-use in clinical dental settings by professionals. Supplied as an aqueous formulation, it is classified under FDA 510(k) clearance (K994181) as a Class II device (regulation number 872.3260). No information on sterility or MRI safety is provided in the specifications.
Frequently asked questions
What is the primary purpose of the Pulpdent Cavity Preparation II, and how does the fluoride variant differ from the standard version?
The Pulpdent Cavity Preparation II is a dental varnish designed to protect and condition dentin during tooth preparation for restorative procedures. Its primary function is to create a barrier that safeguards the tooth structure while preparing it for fillings or other restorative treatments. The fluoride variant, labeled as 'Pulpdent Cavity Preparation II with Fluoride,' includes an additional fluoride component to provide remineralization support, helping to strengthen the tooth enamel and reduce sensitivity after preparation.
Is the Pulpdent Cavity Preparation II intended for single-use or can it be reused?
The Pulpdent Cavity Preparation II is explicitly designed for single-use in clinical dental settings by dental professionals. This ensures sterility and safety for each patient, as reuse could compromise the product’s integrity and potentially introduce contamination.
What form does the Pulpdent Cavity Preparation II come in, and how is it supplied?
The Pulpdent Cavity Preparation II is supplied as an aqueous formulation, meaning it is a liquid solution. While the exact packaging details (e.g., bottle size, applicator type) are not specified in the provided data, it is intended for direct application during dental procedures, likely in a pre-filled, single-use container for convenience in clinical settings.
Are there different sizes or models of the Pulpdent Cavity Preparation II, and how would I identify them?
The data includes multiple registration numbers (e.g., 3038718579, 2523320, etc.), which may correspond to different lot numbers, batch sizes, or minor variants of the product. However, no explicit size or model distinctions (e.g., small/large bottles, different concentrations) are provided in the description. For precise identification, refer to the product labeling or consult Pulpdent Corporation directly, as these registration numbers are administrative and not indicative of clinical variations.
What should I know about storing the Pulpdent Cavity Preparation II to maintain its effectiveness?
While the data does not specify storage conditions like temperature or shelf life, dental varnishes like this are typically stored in a cool, dry place away from direct sunlight to preserve their aqueous formulation and active ingredients. Always follow the manufacturer’s instructions on the packaging for optimal storage, as improper conditions could degrade the product’s performance or stability.
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 Cavity Preparation Ii, Pulpdent Cavity Preparation Ii Wuth ..., PDF K994181 - Pulpdent Cavity Preparation Ii, Pulpdent Cavity Preparation ..., PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY… - FDA.report, www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994181 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K994181 24 fields · synced Sep 18, 2026