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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 K000454
Device Name DIMEX 2
Applicant
Planmeca Oy
362 Balm Ct.
Wood Dale,  IL  60191
Applicant Contact BOB PIENKOWSKI
Correspondent
Planmeca Oy
362 Balm Ct.
Wood Dale,  IL  60191
Correspondent Contact BOB PIENKOWSKI
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/11/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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