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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 K891613
Device Name OVERDENTURE ATTACHMENT
Applicant
IMPLANT INNOVATIONS INTERNATIONAL, INC.
1897 PALM BEACH LAKES BLVD.
SUITE 114
WEST PALM BEACH,  FL  33409
Applicant Contact J LAZZARA
Correspondent
IMPLANT INNOVATIONS INTERNATIONAL, INC.
1897 PALM BEACH LAKES BLVD.
SUITE 114
WEST PALM BEACH,  FL  33409
Correspondent Contact J LAZZARA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/20/1989
Decision Date 10/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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