510(k) K241492

Guided Surgery Kit Cases by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2024
Date Received
May 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type