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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K160506
Device Name Planmeca ProMax 3D Max, Planmeca Maximity
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 Number892.1750
Classification Product Code
OAS  
Date Received02/24/2016
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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