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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 K170080
Device Name Neodent Implant System - CM Pro PEEK Abutment
JJGC Industria e Comercio de Materiais Dentarios SA
Av. Juscelino Kubitschek de Oliveira, 3291 – CIC
Curitiba,  BR 81270-200
Applicant Contact Julianne Lechechem
Straumann USA, LLC
60-100 Minuteman Rd
Andover,  MA  01810
Correspondent Contact Jennifer Jackson
Regulation Number872.3630
Classification Product Code
Date Received01/10/2017
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No