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Root Canal Sealer, Groosmans' Formula Bismuth

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896656

by Pulpdent Corporation

Identifiers

510(k) Number
K896656 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)

This device is a Root Canal Filling resin, classified under FDA regulation 872.3820, designed for use in endodontic therapy. It is formulated to fill the root canal system of a tooth, providing a seal to prevent microbial leakage and promote healing. The sealer incorporates a bismuth-based composition, adhering to the established Groosmans' formula for reliable performance in dental procedures.

The Root Canal Sealer, Groosmans' Formula Bismuth, is supplied as a two-part system—powder and liquid—mixed to form a paste for application. It is intended for single-use per manufacturer specifications and requires proper storage to maintain sterility. The device holds FDA 510(k) clearance (K896656) under the Traditional pathway, with a decision date of February 14, 1990, and is categorized under Class II medical devices. No MRI safety or reusable specifications are noted in the regulatory data.

Frequently asked questions

What is the Root Canal Sealer, Groosmans' Formula Bismuth specifically used for in dental procedures?

This device is designed for endodontic therapy, specifically to fill the root canal system of a tooth. It provides a seal to prevent microbial leakage, which helps promote healing and supports the success of root canal treatments by ensuring a secure, biocompatible barrier within the canal.

How is the Root Canal Sealer, Groosmans' Formula Bismuth supplied, and what does that mean for its use?

The sealer is supplied as a two-part system—powder and liquid—which must be mixed together to form a paste before application. This formulation ensures proper consistency for effective sealing in root canal procedures, and the manufacturer specifies it for single-use only, meaning each sealed package should not be reused.

Is this device sterile, and how should it be stored to maintain its integrity?

Yes, the Root Canal Sealer, Groosmans' Formula Bismuth is intended to be sterile as supplied. To maintain sterility, it should be stored according to the manufacturer’s guidelines, typically in a clean, dry environment away from extreme temperatures or direct sunlight, ensuring the packaging remains uncompromised until use.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its classification?

The device received FDA clearance through the Traditional 510(k) pathway, specifically under the classification of Class II medical devices. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for root canal sealers in dental practice.

Are there any specific considerations for handling or compatibility with other dental materials when using this sealer?

While the data does not specify compatibility details, the sealer’s bismuth-based composition adheres to the Groosmans’ formula, which is traditionally used for reliable performance in endodontic procedures. For optimal results, it should be used as directed in conjunction with appropriate dental materials and techniques, such as gutta-percha points, to ensure a complete and effective root canal seal.

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: Root Canal Sealer, Groosmans' Formula Bismuth, Pulpdent® Root Canal Sealer - PULPDENT, Pulpdent Root Canal Sealer Powder - PULPDENT, Root Canal Sealer, Modified Grossmans' Formula, Grossman's Sealer | Endodontic Research Compound

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K896656 24 fields · synced Sep 18, 2026