Cleared Special

KAVO EVEREST ZH-BLANK (K033221) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033221 · Kavo America Corporation · Dental device
Download Printable Device Report (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.

View all Kavo America Corporation devices

Submission Details

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
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K033221.
DUCERAGOLD PORCELAINS
K040421 · Dentsply Intl. · Mar 2004
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
FINESSE ALL-CERAMIC SYSTEM
K971869 · Dentsply Intl. · Sep 1997