Cleared Traditional

PRE-IMPRESSION CONDITIONING SOLUTION

K061427 · Dentsply Intl. · Dental
Jun 2006
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K061427 is an FDA 510(k) clearance for the PRE-IMPRESSION CONDITIONING SOLUTION, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 26, 2006, 34 days after receiving the submission on May 23, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K061427 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2006
Decision Date June 26, 2006
Days to Decision 34 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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