Cleared Traditional

K040153 - I-TEC PORTABLE DENTAL OPERATORY

K040153 is an FDA 510(k) clearance for I-TEC PORTABLE DENTAL OPERATORY, manufactured by Indigenous Peoples Technology and Education Center. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K040153 · Indigenous Peoples Technology and Education Center · Dental device
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May 2004
Decision
119d
Days
Class 1
Risk

K040153 is an FDA 510(k) clearance for the I-TEC PORTABLE DENTAL OPERATORY. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Indigenous Peoples Technology and Education Center (Dunnellon, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 119 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 Indigenous Peoples Technology and Education Center devices

FDA 510(k) Submission Details - K040153

510(k) Number K040153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date May 21, 2004
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
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 45
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K040153.
X-CUBE
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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
SIROTORQUE L
K031584 · Sirona Dental Systems GmbH · Aug 2003
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068 · W&H Dentalwerk Buermoos GmbH · May 2002