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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Broach, Endodontic
510(k) Number K871493
Device Name DENTI-TRAY(TM)
Applicant
Advanced Medical, Inc.
17744 Sampson Lane-Unit 7
Huntington Beach,  CA  92647
Applicant Contact VICTOR H PEREIRA
Correspondent
Advanced Medical, Inc.
17744 Sampson Lane-Unit 7
Huntington Beach,  CA  92647
Correspondent Contact VICTOR H PEREIRA
Regulation Number872.4565
Classification Product Code
EKW  
Date Received04/16/1987
Decision Date 06/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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