Cleared Traditional

PLANMECA PROMAX 3D MID

K103689 · Planmeca Oy · Radiology
Mar 2011
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K103689 is an FDA 510(k) clearance for the PLANMECA PROMAX 3D MID, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on March 17, 2011, 90 days after receiving the submission on December 17, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K103689 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2010
Decision Date March 17, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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