Cleared Traditional

K131578 - IPROPHY MOBILE

K131578 is the FDA 510(k) clearance for IPROPHY MOBILE by Nakanishi, Inc.. It is a Class 1 Dental device (product code EKX) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K131578 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
104d
Days
Class 1
Risk

K131578 is an FDA 510(k) clearance for the IPROPHY MOBILE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on September 12, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K131578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 32
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K131578.
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PERIOTEST
K872171 · Siemens Medical Solutions USA, Inc. · Jun 1987
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