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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 K150217
Device Name ORTHOPHOS SL
Applicant
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE 64623
Applicant Contact Thomas Diesch
Correspondent
Sirona Dental Systems, Inc.
30-30 47th Ave., Suite 500
Long Island City,  NY  11101
Correspondent Contact Kofi Aninakwa
Regulation Number892.1750
Classification Product Code
OAS  
Date Received01/30/2015
Decision Date 05/08/2015
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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