Cleared Traditional

I-TEC PORTABLE DENTAL OPERATORY (K040153) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

Device Classification

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.