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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 K050970
Device Name MILO DENTAL IMPLANT SYSTEM
Applicant
Intra-Lock International
1200 N. Federal Hwy.
Suite 209
Boca Raton,  FL  33432
Applicant Contact JEFFREY SAKOFF
Correspondent
Intra-Lock International
1200 N. Federal Hwy.
Suite 209
Boca Raton,  FL  33432
Correspondent Contact JEFFREY SAKOFF
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/18/2005
Decision Date 10/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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