Cleared Traditional

PLANMECA PROMAX 3D MAX

K093590 · Planmeca Oy · Radiology

May 2010

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K093590 is an FDA 510(k) clearance for the PLANMECA PROMAX 3D MAX, 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 May 12, 2010, 174 days after receiving the submission on November 19, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K093590 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2009
Decision Date	May 12, 2010
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF