Cleared Traditional

K913946 - IMPERVA DUAL

K913946 is the FDA 510(k) clearance for IMPERVA DUAL by Shofu Dental Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913946 · Shofu Dental Corp. · Dental device
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Dec 1991
Decision
90d
Days
Class 2
Risk

K913946 is an FDA 510(k) clearance for the IMPERVA DUAL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on December 3, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shofu Dental Corp. devices

Submission Details

510(k) Number K913946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1991
Decision Date December 03, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 220
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K913946.
SR-ISOSIT SPECTRA LINK SYSTEM
K910069 · Ivoclar North America, Inc. · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
ESPE(R) -SIL
K913965 · Espe GmbH (Us) · Dec 1991
PULPDENT ENAMEL BONDING AGENT
K911282 · Pulpdent Corp. · Sep 1991
ALL-BOND 2
K910860 · Bisco, Inc. · Apr 1991
ALL BOND LINER-F
K910628 · Bisco, Inc. · Mar 1991