Cleared Traditional

Surgic Pro, Surgic Pro+

K173905 · Nakanishi, Inc. · Dental
Jun 2018
Decision
179d
Days
Class 1
Risk

About This 510(k) Submission

K173905 is an FDA 510(k) clearance for the Surgic Pro, Surgic Pro+, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on June 19, 2018, 179 days after receiving the submission on December 22, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K173905 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2017
Decision Date June 19, 2018
Days to Decision 179 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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