Cleared Traditional

PDS-2000 (K902653) - FDA 510(k) Clearance

Class I Dental device.

K902653 · Intl. Equipment and Supply Corp. · Dental device
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Sep 1990
Decision
90d
Days
Class 1
Risk

K902653 is an FDA 510(k) clearance for the PDS-2000. Classified as Carver, Wax, Dental (product code EIK), Class I - General Controls.

Submitted by Intl. Equipment and Supply Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Intl. Equipment and Supply Corp. devices

Submission Details

510(k) Number K902653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1990
Decision Date September 13, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIK Carver, Wax, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.