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Imperva Dual

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913946

by Shofu Dental Corp.

Identifiers

510(k) Number
K913946 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Imperva Dual is a Class II dental bonding resin agent intended for tooth bonding applications. The product is identified as an agent, tooth bonding, resin in the FDA device classification and is listed under product code KLE.

The device was cleared through a traditional 510(k) submission (K913946) by the FDA on December 3, 1991 and is manufactured by Shofu Dental Corp. in Menlo Park, CA, United States. It is supplied as a powder formulation and is regulated as a dental device; no specific sterility or single‑use information is provided in the available 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: IMPERVA DUAL (K913946) — FDA 510 (k) | Innolitics, msds report | IMPERVA DUAL POWDER by SHOFU DENTAL CORP Material Safety ..., Imperva Dual 510 (k) FDA Premarket Notification K913946 SHOFU DENTAL CORP., Imperva Dual Powder - Free SDS search, PDF K913946 - Imperva Dual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA 510(k) K913946 24 fields · synced Sep 22, 2026