Cleared Special

K033221 - KAVO EVEREST ZH-BLANK

K033221 is an FDA 510(k) clearance for KAVO EVEREST ZH-BLANK, manufactured by Kavo America Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 25-day FDA review.

K033221 · Kavo America Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
25d
Days
Class 2
Risk

K033221 is an FDA 510(k) clearance for the KAVO EVEREST ZH-BLANK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on October 28, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 - K033221

510(k) Number K033221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date October 28, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 128d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K033221.
MATCH MASTER LOW FUSION PORCELAIN
K024252 · Davis Schottlander & Davis, Ltd. · Jan 2004
CERABIEN ZR
K031968 · Noritake Co., Inc. · Dec 2003
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
CZR PRESS
K033049 · Noritake Co., Inc. · Oct 2003
VINTAGE AL
K032165 · Shofu Dental Corp. · Sep 2003
MATCH PRESS PRESSABLE CERAMIC
K024250 · Davis Schottlander & Davis, Ltd. · Aug 2003
K033221 · KAVO EVEREST ZH-BLANK
Download PDF FDA Summary Kavo America Corporat…