Cleared Special

K080130 - OCCLUFAST CAD

K080130 is an FDA 510(k) clearance for OCCLUFAST CAD, 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 56-day FDA review.

K080130 · Zhermack S.P.A. · Dental device
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Mar 2008
Decision
56d
Days
Class 2
Risk

K080130 is an FDA 510(k) clearance for the OCCLUFAST CAD. 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 March 14, 2008 after a review of 56 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.

View all Zhermack S.P.A. devices

FDA 510(k) Submission Details - K080130

510(k) Number K080130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2008
Decision Date March 14, 2008
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 237
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K080130.
COLORISE RIGID
K081084 · Zhermack S.P.A. · May 2008
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008
PECD-01 AND PECD QUICK-01
K080514 · 3M Espe AG Dental Products · Mar 2008
ELITE GLASS
K073005 · Zhermack S.P.A. · Dec 2007
EMULATE ADVANCED
K072245 · Cavex Holland BV · Nov 2007
COLORISE
K070677 · Zhermack S.P.A. · May 2007