510(k) K241492

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

K241492 is an FDA 510(k) premarket notification submitted by JJGC Indústria e Comércio de Materiais Dentários S.A. for the device "Guided Surgery Kit Cases". The FDA issued a decision of Substantially Equivalent on August 23, 2024. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. JJGC Indústria e Comércio de Materiais Dentários S.A. has at least 10 other 510(k) clearances on record.

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