Cleared Traditional

K923461 - PM2002 PROLINE, PM2002 PROLINE EC

K923461 is an FDA 510(k) clearance for PM2002 PROLINE, manufactured by Planmeca USA, Inc.. The device is a Class 1 Dental device with 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

FDA 510(k) Submission Details - K923461

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.

KLC Device Classification - Class 1, General Controls

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 30
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K923461.
A-DEC 2184 DUO UNIT
K925324 · A-Dec, Inc. · Dec 1993
A-DEC 2185 DOCTOR'S UNIT
K925325 · A-Dec, Inc. · Dec 1993
MDT DENTAL CHAIR
K931169 · Mdt Corp., Inc. · May 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