Cleared Traditional

K913946 - IMPERVA DUAL

K913946 is an FDA 510(k) clearance for IMPERVA DUAL, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K913946

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.

KLE Device Classification - Class 2, Special Controls

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 353
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
CLEARFIL LINER BOND SYSTEM
K912707 · Kuraray Co. · Aug 1991
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K912256 · Lee Pharmaceuticals · Jul 1991