Cleared Traditional

K953613 - IMPERVA ENSURABOND

K953613 is the FDA 510(k) clearance for IMPERVA ENSURABOND by Shofu Dental Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K953613 · Shofu Dental Corp. · Dental device
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Oct 1995
Decision
63d
Days
Class 2
Risk

K953613 is an FDA 510(k) clearance for the IMPERVA ENSURABOND. 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 October 4, 1995 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corp. devices

Submission Details

510(k) Number K953613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1995
Decision Date October 04, 1995
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 K953613.
AMALGAMIBOND PLUS
K960879 · Parkell, Inc. · Mar 1996
SILANE PRIMER
K954708 · Sybron Dental Specialties, Inc. · Oct 1995
IMPERVA FLUOROBOND
K953612 · Shofu Dental Corp. · Oct 1995
FUJI BOND LC
K953166 · GC America, Inc. · Sep 1995
BOND-IT DUAL CURE ACTIVATOR
K953859 · Jeneric/Pentron, Inc. · Sep 1995
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
K953527 · Ultradent Products, Inc. · Aug 1995