Cleared Traditional

K970812 - PM 2002 CC PROLINE

K970812 is an FDA 510(k) clearance for PM 2002 CC PROLINE, manufactured by Planmeca Oy. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K970812 · Planmeca Oy · Radiology device
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Aug 1997
Decision
153d
Days
Class 2
Risk

K970812 is an FDA 510(k) clearance for the PM 2002 CC PROLINE. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on August 5, 1997 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Planmeca Oy devices

FDA 510(k) Submission Details - K970812

510(k) Number K970812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1997
Decision Date August 05, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 78
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K970812.
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
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K974077 · J. Morita USA, Inc. · Jan 1998
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K973476 · Eastman Kodak Company · Nov 1997
PROSTYLE INTRA
K970975 · Planmeca Oy · Apr 1997
PM 2002 CC PROLINE
K970263 · Planmeca Oy · Feb 1997
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
K964659 · Dentsply Intl. · Dec 1996