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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K093590
Device Name PLANMECA PROMAX 3D MAX
Applicant
Planmeca Oy
Asentajankatu 6
Helsinki,  FI 00880
Applicant Contact LARS MORING
Correspondent
Planmeca Oy
Asentajankatu 6
Helsinki,  FI 00880
Correspondent Contact LARS MORING
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/19/2009
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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