Cleared Traditional

K990954 - ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET

K990954 is an FDA 510(k) clearance for ELEC-MATE, 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 79-day FDA review.

K990954 · Nsk Nakanishi, Inc. · Dental device
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Jun 1999
Decision
79d
Days
Class 1
Risk

K990954 is an FDA 510(k) clearance for the ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET. 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 June 9, 1999 after a review of 79 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 - K990954

510(k) Number K990954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date June 09, 1999
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
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 K990954.
ELEC-MATE E
K011926 · Nakanishi, Inc. · Sep 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469 · W&H Dentalwerk Buermoos GmbH · Feb 2001
ROTARY MASTER
K992648 · J. Morita USA, Inc. · Jan 2000
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
K972889 · W & H Dentalwerk · Jan 1998
SURGIC II IMPLANT CONTROL UNIT
K972924 · Nsk Nakanishi, Inc. · Oct 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · Bell Intl., Inc. · Mar 1997