Cleared Traditional

K102739 - HYDROCOLOR 5

K102739 is an FDA 510(k) clearance for HYDROCOLOR 5, manufactured by Cascades Device Consulting Associates. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K102739 · Cascades Device Consulting Associates · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
77d
Days
Class 2
Risk

K102739 is an FDA 510(k) clearance for the HYDROCOLOR 5. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cascades Device Consulting Associates (Bend, US). The FDA issued a Cleared decision on December 8, 2010 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Cascades Device Consulting Associates devices

FDA 510(k) Submission Details - K102739

510(k) Number K102739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date December 08, 2010
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 262
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K102739.
FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011
TAKE 1 ADVANCED RIGID TRAY
K110092 · Kerr Corporation · Apr 2011
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
VONFLEX HEAVY, VINFLEX LIGHT
K103164 · Vericom Co., Ltd. · Nov 2010
TAKE 1 ADVANCED RIGID TRAY
K092176 · Kerr Corporation · Jan 2010
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009