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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 K230804
Device Name Complement Kit Cases
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
Av. Juscelino Kubitschek De Oliveira, 3291 – Cic
Curitiba,  BR 81270-200
Applicant Contact Barbara Uzae
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M Jackson
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/23/2023
Decision Date 07/07/2023
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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