Identifiers
- 510(k) Number
- K946138 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 Root Canal Sealer is a resin-based material classified as a root canal filling substance. It is designed to provide a permanent seal within the root canal system, ensuring complete obturation by filling irregularities and accessory canals through extrusion via a 30-gauge needle using the Pressure Syringe technique.
This liquid-form sealer is supplied in sterile, single-use containers of 60 mL or 7.5 mL and is intended for use in endodontic procedures. It is regulated under FDA 510(k) clearance (K946138) as a Class II device (regulation number 872.3820) and adheres to dental specialty standards. The material is non-reusable and must be stored according to manufacturer guidelines to maintain sterility and efficacy.
Frequently asked questions
What is the Pulpdent Root Canal Sealer used for in endodontic procedures?
The Pulpdent Root Canal Sealer is a resin-based material designed specifically to create a permanent seal within the root canal system. It fills irregularities and accessory canals by being extruded through a 30-gauge needle using the Pressure Syringe technique, ensuring complete obturation during root canal treatments.
How is the Pulpdent Root Canal Sealer supplied, and is it reusable?
The sealer comes in sterile, single-use containers, available in two sizes: 60 mL or 7.5 mL. Since it is explicitly labeled as non-reusable, each container is intended for one-time use only to maintain sterility and efficacy.
What storage instructions should I follow to keep the Pulpdent Root Canal Sealer effective?
The manufacturer provides specific storage guidelines to preserve sterility and performance. While the exact conditions aren’t detailed here, it’s critical to follow the instructions provided by Pulpdent Corporation to ensure the material remains viable for use in endodontic procedures.
Are there different sizes or models of the Pulpdent Root Canal Sealer, and how do I identify them?
The device is supplied in two distinct container sizes: 60 mL and 7.5 mL. These sizes are likely intended for different procedural needs or practice volumes, but the core material and application method remain consistent across both. Always verify the label to confirm the correct size for your use.
How was the regulatory pathway for the Pulpdent Root Canal Sealer determined, and what does that mean for its use?
The Pulpdent Root Canal Sealer was cleared through the FDA’s 510(k) process (K946138) under the Traditional pathway, classified as a Class II device (regulation number 872.3820). This means it was determined to be substantially equivalent to a legally marketed predicate device, adhering to dental specialty standards for root canal filling substances. The clearance does not imply its clinical indication but confirms its compliance with regulatory requirements.
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 Root Canal Sealer Liquid - PULPDENT, Pulpdent Root Canal Sealer - safcodental.com, Pulpdent Root Canal Sealer | ODS HealthCare - odshc.com, Root Canal Sealer - Pulpdent, Liquid, 60 mL - myoralcareshop.com, Root Canal Sealer - Pulpdent, Liquid, 7.5 mL - orallycare.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K946138 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K946138 24 fields · synced Sep 18, 2026