Cleared Traditional

Cavex Cream Alginate

K151535 · Cavex Holland BV · Dental
Oct 2015
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K151535 is an FDA 510(k) clearance for the Cavex Cream 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 October 28, 2015, 142 days after receiving the submission on June 8, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K151535 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2015
Decision Date October 28, 2015
Days to Decision 142 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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