510(k) K192033

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip by Bennett Jacoby, Dds, Ms, Inc. — Product Code DZI

K192033 is an FDA 510(k) premarket notification submitted by Bennett Jacoby, Dds, Ms, Inc. for the device "Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip". The FDA issued a decision of Substantially Equivalent on June 9, 2020. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120.