Cleared Traditional

K953592 - REVOLUTION BOND

K953592 is an FDA 510(k) clearance for REVOLUTION BOND, manufactured by E&D Dental Products, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K953592 · E&D Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
37d
Days
Class 2
Risk

K953592 is an FDA 510(k) clearance for the REVOLUTION BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by E&D Dental Products, Inc. (Somerset, US). The FDA issued a Cleared decision on September 7, 1995 after a review of 37 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 E&D Dental Products, Inc. devices

FDA 510(k) Submission Details - K953592

510(k) Number K953592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date September 07, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
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 383
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K953592.
IMPERVA FLUOROBOND
K953612 · Shofu Dental Corp. · Oct 1995
IMPERVA ENSURABOND
K953613 · 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
MS EMULSION
K952123 · Parkell, Inc. · Jun 1995