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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 K083297
Device Name PITT-EASY DENTAL IMPLANT SYSTEM
Applicant
Sybron Implant Solutions GmbH
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Wendy Garman
Correspondent
Sybron Implant Solutions GmbH
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/10/2008
Decision Date 01/28/2009
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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