Cleared Traditional

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE

K100539 · Preventive Technologies, Inc. · Dental
Jun 2010
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K100539 is an FDA 510(k) clearance for the PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Preventive Technologies, Inc. (Indian Trial, US). The FDA issued a Cleared decision on June 17, 2010, 112 days after receiving the submission on February 25, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K100539 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2010
Decision Date June 17, 2010
Days to Decision 112 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