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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 K122199
Device Name PREXION3D ECLIPSE
Applicant
The Yoshida Dental Mfg. Co., Ltd.
1-14-1 Kandasuda-Cho
Funai Tokyo Technology Ctr Bldg. 10f
Chiyoda-Ku, Tokyo,  JP 101-0041
Applicant Contact TOSHIMITSU MURAKAMI
Correspondent
The Yoshida Dental Mfg. Co., Ltd.
1-14-1 Kandasuda-Cho
Funai Tokyo Technology Ctr Bldg. 10f
Chiyoda-Ku, Tokyo,  JP 101-0041
Correspondent Contact TOSHIMITSU MURAKAMI
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/24/2012
Decision Date 04/18/2013
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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