Cleared Traditional

REMIN PRO

K101104 · Voco GmbH · Dental
Oct 2010
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K101104 is an FDA 510(k) clearance for the REMIN PRO, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on October 21, 2010, 184 days after receiving the submission on April 20, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K101104 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2010
Decision Date October 21, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJR — Agent, Polishing, Abrasive, Oral Cavity
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6030

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