Cleared Special

KAVO EVEREST ZH-BLANK

K033221 · Kavo America Corporation · Dental
Oct 2003
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K033221 is an FDA 510(k) clearance for the KAVO EVEREST ZH-BLANK, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on October 28, 2003, 25 days after receiving the submission on October 3, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K033221 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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