K233117

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

510(k) number
K233117
Device name
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
Applicant
Nakanishi, Inc. JP
Product code
EBW — Controller, Foot, Handpiece And Cord
Decision date
2024-06-20
Date received
2023-09-27
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K233117.pdf

Official FDA record: K233117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.