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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 K111199
Device Name INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
Applicant
INTRA-LOCK INTERNATIONAL, INC.
6560 WEST ROGERS CIRCLE
BOCA RATON,  FL  33487
Applicant Contact ANGELA BLACKWELL
Correspondent
INTRA-LOCK INTERNATIONAL, INC.
6560 WEST ROGERS CIRCLE
BOCA RATON,  FL  33487
Correspondent Contact ANGELA BLACKWELL
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/28/2011
Decision Date 08/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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