Cleared Traditional

K233117 - Surgic Pro2 (Surgic Pro2 OPT)

K233117 is the FDA 510(k) clearance for Surgic Pro2 (Surgic Pro2 OPT) by Nakanishi, Inc.. It is a Class 1 Dental device (product code EBW) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K233117 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
267d
Days
Class 1
Risk

K233117 is an FDA 510(k) clearance for the Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on June 20, 2024 after a review of 267 days - an extended review cycle.

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 K233117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
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 - EBW Controller, Foot, Handpiece And Cord

All 30
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