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Spee-Dee Patch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113617

by Pulpdent Corporation

Identifiers

510(k) Number
K113617 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Spee-Dee Patch is a visible light-cured, glass-filled resin classified as a tooth shade resin material (21 CFR 872.3690). It functions as a vital tooth build-up material, designed to restore dental structure and provide durable support during restorative procedures.

Supplied as a single-use dental material, the Spee-Dee Patch is intended for use in clinical dental settings. It requires curing under visible light and is regulated under the FDA’s 510(k) clearance process (K113617), with no explicit mention of MRI safety or sterility requirements in the available data. The product is distributed by Pulpdent Corporation and adheres to dental advisory committee classifications.

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: Spee-Dee™ Build-up - PULPDENT, SPEE-DEE PATCH (K113617) — FDA 510(k) | Innolitics, SPEE-DEE PATCH by PULPDENT CORPORATION | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K113617 24 fields · synced Sep 18, 2026