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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 K950204
Device Name 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
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 Received01/18/1995
Decision Date 09/27/1995
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
Recalls CDRH Recalls
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