Cleared Special

K024034 - OCCLUFAST ROCK

K024034 is an FDA 510(k) clearance for OCCLUFAST ROCK, 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 12-day FDA review.

K024034 · Zhermack S.P.A. · Dental device
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Dec 2002
Decision
12d
Days
Class 2
Risk

K024034 is an FDA 510(k) clearance for the OCCLUFAST ROCK. 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 December 18, 2002 after a review of 12 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 - K024034

510(k) Number K024034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2002
Decision Date December 18, 2002
Days to Decision 12 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
116d faster than avg
Panel avg: 128d · This submission: 12d
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
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