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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K034035
Device Name 3I PATIENT-SPECIFIC OVERDENTURE BAR
Applicant
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact JIM BANIC
Correspondent
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact JIM BANIC
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/29/2003
Decision Date 03/24/2004
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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