Cleared Traditional

K923534 - PM2002 PROLINE (FDA 510(k) Clearance)

Class I Dental device.

K923534 · Planmeca USA, Inc. · Dental device
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Jan 1994
Decision
564d
Days
Class 1
Risk

K923534 is an FDA 510(k) clearance for the PM2002 PROLINE. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on January 31, 1994 after a review of 564 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - 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 Planmeca USA, Inc. devices

Submission Details

510(k) Number K923534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date January 31, 1994
Days to Decision 564 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
437d slower than avg
Panel avg: 127d · This submission: 564d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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.