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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 K080598
Device Name MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
Applicant
INTRA-LOCK INTERNATIONAL
6560 WEST ROGERS CIRCLE
SUITE 24
BOCA RATON,  FL  33487
Applicant Contact JEFFREY SAKOFF
Correspondent
INTRA-LOCK INTERNATIONAL
6560 WEST ROGERS CIRCLE
SUITE 24
BOCA RATON,  FL  33487
Correspondent Contact JEFFREY SAKOFF
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/03/2008
Decision Date 05/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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