Cleared Traditional

K083252 - NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM

K083252 is an FDA 510(k) clearance for NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM, manufactured by Dentalez Group, Stardental Division. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K083252 · Dentalez Group, Stardental Division · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
106d
Days
Class 1
Risk

K083252 is an FDA 510(k) clearance for the NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Dentalez Group, Stardental Division (Lancaster, US). The FDA issued a Cleared decision on February 18, 2009 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Dentalez Group, Stardental Division devices

FDA 510(k) Submission Details - K083252

510(k) Number K083252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date February 18, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 38
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K083252.
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
K133776 · A-Dec, Inc. · May 2014
E3 TORQUE CONTROL MOTOR
K103653 · Dentsply International, Inc. · May 2011
X-CUBE
K092758 · Saeshin Precision Co., Ltd. · Sep 2009
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287 · W&H Dentalwerk Buermoos GmbH · May 2006
IMPLANTMED SI-915 (115V VERSION)
K052741 · W&H Dentalwerk Buermoos GmbH · Jan 2006
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · A-Dec, Inc. · Dec 2003