Cleared Traditional

IPROPHY MOBILE

K131578 · Nakanishi, Inc. · Dental
Sep 2013
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K131578 is an FDA 510(k) clearance for the IPROPHY MOBILE, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on September 12, 2013, 104 days after receiving the submission on May 31, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K131578 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2013
Decision Date September 12, 2013
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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