Pulpdent Calcium Hydroxide Preparation
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022734 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Calcium Hydroxide Preparation is a resin-based root canal filling material designed for dental applications. It is classified as a root canal filling material and is used primarily in endodontic procedures to promote pulp healing, manage dental pulp exposure, and treat periapical pathologies.
This preparation is supplied as a single-use dental material, intended for use in clinical settings by dental professionals. It is not sterile at the point of sale but is packaged in a manner suitable for aseptic preparation in a dental operatory. The device is regulated under FDA 510(k) clearance (K022734) and falls under Class II medical devices, adhering to regulatory standards for dental materials.
Frequently asked questions
What is the primary clinical purpose of the Pulpdent Calcium Hydroxide Preparation in endodontic procedures?
The Pulpdent Calcium Hydroxide Preparation is designed to promote pulp healing, manage dental pulp exposure, and treat periapical pathologies during root canal procedures. It acts as a resin-based root canal filling material to support tissue regeneration and infection control in dental treatments.
Is this product sterile at the time of purchase, and how should it be prepared for clinical use?
No, the Pulpdent Calcium Hydroxide Preparation is not sterile at the point of sale. It is packaged for aseptic preparation in a dental operatory, meaning it must be prepared under sterile conditions by the clinician before use in clinical settings.
How is this device supplied, and is it intended for single-use or reuse?
The Pulpdent Calcium Hydroxide Preparation is supplied as a single-use dental material, intended exclusively for clinical use by dental professionals. This ensures consistency and sterility per procedure, avoiding cross-contamination risks.
What regulatory pathway does this device follow, and what class does it belong to?
The Pulpdent Calcium Hydroxide Preparation follows the FDA 510(k) clearance pathway, specifically under the traditional review process, and is classified as a Class II medical device. This classification aligns with its use as a dental material requiring performance standards and regulatory oversight.
Are there multiple sizes or models available for this product, and how can I identify them?
The product is listed under multiple registration numbers (e.g., 3002807757, 3003120666, etc.) and FEI numbers, which may correspond to different sizes or models. These identifiers are used for regulatory tracking and inventory management, but specific clinical sizes or models are not detailed in the provided data.
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: Multi-Cal™ - PULPDENT, Calcium Hydroxide Archives - PULPDENT, Multi-Cal ™ (Pulpdent) | Pearson Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022734 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K022734 24 fields · synced Sep 18, 2026