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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 128d · 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 Consultant

Dekra Certification B.V
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K083252.
X-CUBE
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K060287 · W&H Dentalwerk Buermoos GmbH · May 2006
IMPLANTMED SI-915 (115V VERSION)
K052741 · W&H Dentalwerk Buermoos GmbH · Jan 2006
IRRIGATION TUBING SET 2.2M AND 3.8M
K041124 · W&H Dentalwerk Burmoos · Jun 2004
K083252 · NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
Download PDF FDA Summary Dentalez Group, Stard…