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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 K082800
Device Name STAR/VENT INTERNAL HEX SCREW IMPLANT
Applicant
Park Dental Research Corp.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Applicant Contact DANIEL J MANELLI
Correspondent
Park Dental Research Corp.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/24/2008
Decision Date 08/26/2010
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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