Cleared Traditional

NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN

K121698 · Dentsply International, Inc. · Dental
Aug 2012
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K121698 is an FDA 510(k) clearance for the NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on August 6, 2012, 59 days after receiving the submission on June 8, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K121698 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2012
Decision Date August 06, 2012
Days to Decision 59 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