Cleared Traditional

K990646 - PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

K990646 is an FDA 510(k) clearance for PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, manufactured by Nsk Nakanishi, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K990646 · Nsk Nakanishi, Inc. · Dental device
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Mar 1999
Decision
18d
Days
Class 1
Risk

K990646 is an FDA 510(k) clearance for the PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on March 19, 1999 after a review of 18 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 - K990646

510(k) Number K990646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date March 19, 1999
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

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

All 69
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K990646.
ENDOSTEPPER 1
K993188 · Phytron- Elektronik GmbH · Sep 1999
QUANTEC-E ENDO SYSTEM
K990739 · Sybron Dental Specialties, Inc. · May 1999
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
K990682 · Nsk Nakanishi, Inc. · Mar 1999
MODEL MS-1 HANDPIECE
K983413 · Parkell, Inc. · Dec 1998
TRI AUTO ZX
K970339 · J. Morita USA, Inc. · Jun 1997
MODIFIED SITE POWER HANDPIECE II
K932600 · Chiron Vision Corp. · Jan 1994