Cleared Traditional

K923461 - PM2002 PROLINE

K923461 is the FDA 510(k) clearance for PM2002 PROLINE by Planmeca USA, Inc.. It is a Class 1 Dental device (product code KLC) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K923461 · Planmeca USA, Inc. · Dental device
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Dec 1992
Decision
160d
Days
Class 1
Risk

K923461 is an FDA 510(k) clearance for the PM2002 PROLINE, PM2002 PROLINE EC. 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 December 21, 1992 after a review of 160 days - an extended review cycle.

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: 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 Planmeca USA, Inc. devices

Submission Details

510(k) Number K923461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date December 21, 1992
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
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.

Regulatory Peers - KLC Chair, Dental, With Operative Unit

All 22
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K923461.
A-DEC 2183 DUO UNIT, CUSP
K925323 · A-Dec, Inc. · Dec 1993
A-DEC 2184 DUO UNIT
K925324 · A-Dec, Inc. · Dec 1993
A-DEC 2185 DOCTOR'S UNIT
K925325 · A-Dec, Inc. · Dec 1993
A-DEC DECADE 1020 CHAIR
K913535 · A-Dec, Inc. · Oct 1991
A-DEC KNEEBREAK 1030 CHAIR
K913059 · A-Dec, Inc. · Oct 1991
A-DEC DECADE 1015 CHAIR
K903450 · A-Dec, Inc. · Oct 1990