Cleared Traditional

K972924 - SURGIC II IMPLANT CONTROL UNIT

K972924 is an FDA 510(k) clearance for SURGIC II IMPLANT CONTROL UNIT, manufactured by Nsk Nakanishi, Inc.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972924 · Nsk Nakanishi, Inc. · Dental device
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Oct 1997
Decision
83d
Days
Class 1
Risk

K972924 is an FDA 510(k) clearance for the SURGIC II IMPLANT CONTROL UNIT. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on October 30, 1997 after a review of 83 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 Nsk Nakanishi, Inc. devices

FDA 510(k) Submission Details - K972924

510(k) Number K972924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1997
Decision Date October 30, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

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 50
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K972924.
ROTARY MASTER
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