Cleared Special

K000120 - PRO-TORQ

K000120 is an FDA 510(k) clearance for PRO-TORQ, manufactured by Micro Motors, Inc.. The device is a Class 1 Dental device with product code EBW cleared through the Special 510(k) pathway after a 16-day FDA review.

K000120 · Micro Motors, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
16d
Days
Class 1
Risk

K000120 is an FDA 510(k) clearance for the PRO-TORQ. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Micro Motors, Inc. (Irvine, US). The FDA issued a Cleared decision on February 3, 2000 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micro Motors, Inc. devices

FDA 510(k) Submission Details - K000120

510(k) Number K000120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date February 03, 2000
Days to Decision 16 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K000120.
SURGIC IV IMPLANT CONTROL UNIT
K020327 · Nakanishi, Inc. · Apr 2002
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