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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 AVENUE
SUITE 500
LONG ISLAND,  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
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