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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K954347
Device Name 3I STANDARD THREADED IMPLANT
Applicant
Implant Innovations, Inc.
3071 Continental Dr.
West Palm Baeach,  FL  33407
Applicant Contact WILLIAM G CONETY
Correspondent
Implant Innovations, Inc.
3071 Continental Dr.
West Palm Baeach,  FL  33407
Correspondent Contact WILLIAM G CONETY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/18/1995
Decision Date 04/01/1996
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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