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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 K021322
Device Name ENDOSSOUS IMPLANTS
Applicant
Intra-Lock International
1200 N. Federal Hwy
Suite 200
Boca Raton,  FL  33432
Applicant Contact JEFFERY SAKOFF
Correspondent
Intra-Lock International
1200 N. Federal Hwy
Suite 200
Boca Raton,  FL  33432
Correspondent Contact JEFFERY SAKOFF
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/25/2002
Decision Date 07/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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