Cleared Traditional

IMPRESSIX, COLORCHANGE ALGINATE

K062400 · Cavex Holland BV · Dental
Nov 2006
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K062400 is an FDA 510(k) clearance for the IMPRESSIX, COLORCHANGE ALGINATE, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on November 16, 2006, 92 days after receiving the submission on August 16, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K062400 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2006
Decision Date November 16, 2006
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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