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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K142625
Device Name PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Applicant Contact Michio Takigawa
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Correspondent Contact Michio Takigawa
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/16/2014
Decision Date 01/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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