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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 K960417
Device Name 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS
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 Received01/29/1996
Decision Date 08/01/1996
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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