Cleared Traditional

K070677 - COLORISE

K070677 is an FDA 510(k) clearance for COLORISE, manufactured by Zhermack S.P.A.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K070677 · Zhermack S.P.A. · Dental device
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May 2007
Decision
60d
Days
Class 2
Risk

K070677 is an FDA 510(k) clearance for the COLORISE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack S.P.A. (Bend, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 60 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 Zhermack S.P.A. devices

FDA 510(k) Submission Details - K070677

510(k) Number K070677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date May 11, 2007
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
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 237
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K070677.
OCCLUFAST CAD
K080130 · Zhermack S.P.A. · Mar 2008
ELITE GLASS
K073005 · Zhermack S.P.A. · Dec 2007
EMULATE ADVANCED
K072245 · Cavex Holland BV · Nov 2007
FREEALGIN
K070700 · Zhermack S.P.A. · Apr 2007
IMPRESSIX, COLORCHANGE ALGINATE
K062400 · Cavex Holland BV · Nov 2006
VIRTUAL
K060891 · Ivoclar Vivadent, Inc. · Jul 2006