Root Canal Sealer, Modified Grossmans' Formula
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K896657 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 Resin, Root Canal Filling as classified by the FDA, designed for use in endodontic therapy. It is a modified Grossman’s formula root canal sealer composed of a powder-liquid system, intended to fill and seal the root canal system of teeth during endodontic procedures. The formulation combines zinc oxide, zinc stearate, calcium phosphate, barium sulfate, eugenol, and Canada balsam to provide a reliable seal.
The sealer is supplied as a two-part system (powder and liquid) and is used in conjunction with various filling techniques, including pressure syringe application, lateral condensation, or paste filler methods. It is intended for both primary and permanent teeth and is classified as a Class II device under FDA regulation 872.3820. The product received FDA 510(k) clearance (K896657) in 1990 and is manufactured by Pulpdent Corporation in Watertown, Massachusetts.
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, Modified Grossmans' Formula, Pulpdent® Root Canal Sealer - PULPDENT, PDF K896657 - Root Canal Sealer, Modified Grossmans' Formula, fda.innolitics.com, Pulpdent Root Canal Sealer Powder - PULPDENT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896657 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K896657 24 fields · synced Sep 18, 2026