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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 K871862
Device Name POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER
Applicant
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Applicant Contact LAZZARA, DMD
Correspondent
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Correspondent Contact LAZZARA, DMD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/13/1987
Decision Date 07/10/1987
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
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