Cleared Traditional

SIMULATE, COLOR CHANGE ALGINATE

K061267 · Cavex Holland BV · Dental
Jul 2006
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K061267 is an FDA 510(k) clearance for the SIMULATE, COLOR CHANGE 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 July 10, 2006, 66 days after receiving the submission on May 5, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K061267 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2006
Decision Date July 10, 2006
Days to Decision 66 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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