Cleared Traditional

K904948 - PM2002 CC AND PM2002 EC

K904948 is the FDA 510(k) clearance for PM2002 CC AND PM2002 EC by Planmeca USA, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K904948 · Planmeca USA, Inc. · Dental device
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Jan 1991
Decision
90d
Days
Class 1
Risk

K904948 is an FDA 510(k) clearance for the PM2002 CC AND PM2002 EC. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on January 30, 1991 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 872.6640 - 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: 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 K904948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1990
Decision Date January 30, 1991
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 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 63
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K904948.
A-DEC 2612 ASSISTANT'S CART
K933163 · A-Dec, Inc. · Oct 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165 · A-Dec, Inc. · Oct 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · A-Dec, Inc. · Oct 1993
A-DEC PAC I PORTABLE UNIT
K903451 · A-Dec, Inc. · Oct 1990
A-DEC IC CONTROL HEAD
K903452 · A-Dec, Inc. · Oct 1990
A-DEC IC MICRO-CART
K903453 · A-Dec, Inc. · Oct 1990