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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 K130572
Device Name INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
Applicant
IMPLANT DIRECT SYBRON MANUFACTURING LLC
27030 MALIBU HILLS RD
CALABASAS,  CA  91301
Applicant Contact INES ARAVENA
Correspondent
IMPLANT DIRECT SYBRON MANUFACTURING LLC
27030 MALIBU HILLS RD
CALABASAS,  CA  91301
Correspondent Contact INES ARAVENA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/04/2013
Decision Date 12/24/2013
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
Recalls CDRH Recalls
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