Cleared Traditional

K110278 - CORDLESS PROSTHODONTIC SCREWDRIVER WITH...

K110278 is the FDA 510(k) clearance for CORDLESS PROSTHODONTIC SCREWDRIVER WITH... by Nakanishi, Inc.. It is a Class 1 Dental device (product code EKX) cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K110278 · Nakanishi, Inc. · Dental device
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Feb 2012
Decision
380d
Days
Class 1
Risk

K110278 is an FDA 510(k) clearance for the CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on February 15, 2012 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K110278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date February 15, 2012
Days to Decision 380 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
253d slower than avg
Panel avg: 127d · This submission: 380d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
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 - EKX Handpiece, Direct Drive, Ac-powered

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