Cleared Traditional

PRO-SCOPE MODEL # PS-4000 (K922942) - FDA 510(k) Clearance

Class I Dental device.

K922942 · Pro-Den Systems, Inc. · Dental device
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Sep 1993
Decision
449d
Days
Class 1
Risk

K922942 is an FDA 510(k) clearance for the PRO-SCOPE MODEL # PS-4000. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pro-Den Systems, Inc. (Portland, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Pro-Den Systems, Inc. devices

Submission Details

510(k) Number K922942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date September 10, 1993
Days to Decision 449 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
322d slower than avg
Panel avg: 127d · This submission: 449d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K922942.
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K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979