Cleared Traditional

SURGIC IV IMPLANT CONTROL UNIT (K020327) - FDA 510(k) Clearance

Class I Dental device.

K020327 · Nakanishi, Inc. · Dental device
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Apr 2002
Decision
67d
Days
Class 1
Risk

K020327 is an FDA 510(k) clearance for the SURGIC IV IMPLANT CONTROL UNIT. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on April 8, 2002 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K020327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2002
Decision Date April 08, 2002
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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 60
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