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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 K120948
Device Name PREXION 3D
Applicant
The Yoshida Dental Mfg. Co., Ltd.
1-3-6 Kotobashi, Sumida-Ku
Tokyo,  JP 130-8516
Applicant Contact HIDENORI WATANABE
Correspondent
The Yoshida Dental Mfg. Co., Ltd.
1-3-6 Kotobashi, Sumida-Ku
Tokyo,  JP 130-8516
Correspondent Contact HIDENORI WATANABE
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/29/2012
Decision Date 12/21/2012
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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