Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Surgic Pro, Surgic Pro+

K-Number: K173905 · 2018-06-19

ApplicantNakanishi, Inc.
Decision Date2018-06-19
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgic Pro, Surgic Pro+ is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2018-06-19 under 510(k) number K173905. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgic Pro, Surgic Pro+?

Surgic Pro, Surgic Pro+ is a medical device that received FDA 510(k) clearance on 2018-06-19. The listed applicant is Nakanishi, Inc.. The 510(k) number is K173905.

When did Surgic Pro, Surgic Pro+ receive FDA 510(k) clearance?

Surgic Pro, Surgic Pro+ received FDA 510(k) clearance on 2018-06-19, under 510(k) number K173905.

Who is the listed applicant for Surgic Pro, Surgic Pro+?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgic Pro, Surgic Pro+?

The FDA product code for Surgic Pro, Surgic Pro+ is EBW.

Other records listing Nakanishi, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260773Varios Combi Pro2K254163VarioSurg 4K252662UniBurK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)K233288NLZ Built-In Motor System

View all 21 devices →

Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑