Cleared Traditional

Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

K233117 · Nakanishi, Inc. · Dental
Jun 2024
Decision
267d
Days
Class 1
Risk

About This 510(k) Submission

K233117 is an FDA 510(k) clearance for the Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT), a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on June 20, 2024, 267 days after receiving the submission on September 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K233117 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date June 20, 2024
Days to Decision 267 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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