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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K192670
Device Name Neodent Instrument Kit Cases
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Av. Juscelino Kubitschek De Oliveira, 3291- Cic
Curitiba,  BR 8127 0-200
Applicant Contact Luiza Vaccari Toppel
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/25/2019
Decision Date 12/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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