Cleared Special

K081084 - COLORISE RIGID

K081084 is an FDA 510(k) clearance for COLORISE RIGID, manufactured by Zhermack S.P.A.. The device is a Class 2 Dental device with product code ELW cleared through the Special 510(k) pathway after a 28-day FDA review.

K081084 · Zhermack S.P.A. · Dental device
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May 2008
Decision
28d
Days
Class 2
Risk

K081084 is an FDA 510(k) clearance for the COLORISE RIGID. 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 14, 2008 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081084

510(k) Number K081084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date May 14, 2008
Days to Decision 28 days
Submission Type Special
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
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 360
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K081084.
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
K082560 · Kettenbach GmbH & Co. KG · Sep 2008
KETTOSIL AND SILGINAT
K082157 · Kettenbach GmbH & Co. KG · Aug 2008
TEMPLATE AND COUNTER-FIT
K081017 · Clinician'S Choice Dental Products, Inc. · Aug 2008
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS
K081120 · Kettenbach GmbH & Co. KG · May 2008
CUTTERSIL ACTIVATOR UNIVERSAL PLUS
K080338 · Heraeus Kulzer,GmbH · Apr 2008
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008