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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 K092261
Device Name DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
Applicant
Impladent, S.L.
Pol.Lnd Mas D'En Cisa
C/ Gato Perez 3-9
Sentmenat, Barcelona,  ES 08181
Applicant Contact JOSE-RAMON GUTIERREZ
Correspondent
Impladent, S.L.
Pol.Lnd Mas D'En Cisa
C/ Gato Perez 3-9
Sentmenat, Barcelona,  ES 08181
Correspondent Contact JOSE-RAMON GUTIERREZ
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/28/2009
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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