Cleared Traditional

K140976 - ENADEN FLOW

K140976 is an FDA 510(k) clearance for ENADEN FLOW, manufactured by Km Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K140976 · Km Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
85d
Days
Class 2
Risk

K140976 is an FDA 510(k) clearance for the ENADEN FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Km Corporation (Fullerton, US). The FDA issued a Cleared decision on July 10, 2014 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Km Corporation devices

FDA 510(k) Submission Details - K140976

510(k) Number K140976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2014
Decision Date July 10, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 690
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K140976.
Admira Fusion
K150784 · Voco GmbH · Jul 2015
TETRIC EVOFLOW BULK FILL
K150393 · Ivoclar Vivadent, AG · Jun 2015
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
ABSOLUTE DENTIN 2
K132115 · Parkell, Inc. · Jun 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · Prismatik Dentalcraft, Inc. · Jun 2014
HTFX-222
K133182 · GC America, Inc. · Apr 2014