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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 K012911
Device Name 3I LOCATER ABUTMENT SYSTEM
Applicant
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact JACQUELYN A HUGHES
Correspondent
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact JACQUELYN A HUGHES
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/30/2001
Decision Date 09/28/2001
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
Recalls CDRH Recalls
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