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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 K073713
Device Name BLUE SKY BIO DENTAL IMPLANT SYSTEM
Applicant
Blue Sky Bio, LLC
888 E. Belvidere Rd., Suite 212
Grayslake,  IL  60030
Applicant Contact MICHELE VOVOLKA
Correspondent
Blue Sky Bio, LLC
888 E. Belvidere Rd., Suite 212
Grayslake,  IL  60030
Correspondent Contact MICHELE VOVOLKA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/31/2007
Decision Date 03/28/2008
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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