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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K170588
Device Name DESS Dental Smart Solutions
Applicant
Terrats Medical SL
Avenida La Ferreria (Pol Ind Ferreria) 62
montcada i reixac,  ES 08110
Applicant Contact roger terrats
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda k. schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/28/2017
Decision Date 08/08/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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