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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture Preformed (Partially Prefabricated Denture)
510(k) Number K892255
Device Name DENTAL ROOT ELEVATOR
Applicant
Zinnanti Surgical Instruments, Inc.
21540-B Prairie St.
Chatsworth,  CA  91311
Applicant Contact ANTHONY ZINNANTI
Correspondent
Zinnanti Surgical Instruments, Inc.
21540-B Prairie St.
Chatsworth,  CA  91311
Correspondent Contact ANTHONY ZINNANTI
Regulation Number872.3600
Classification Product Code
EKO  
Date Received04/04/1989
Decision Date 05/01/1989
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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