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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 K153064
FOIA Releasable 510(k) K153064
Device Name Blue Sky Bio Zygomatic Implant System
Applicant
Blue Sky Bio, LLC
888 E. Belvidere Rd., Suite 212
Grayslake,  IL  60030
Applicant Contact Michele Vovolka
Correspondent
Paxmed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/22/2015
Decision Date 04/29/2016
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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