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FDA 510(k)

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip

K-Number: K192033 · 2020-06-09

ApplicantBennett Jacoby, Dds, Ms, Inc.
Decision Date2020-06-09
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is a medical device manufactured by Bennett Jacoby, Dds, Ms, Inc.. It received FDA 510(k) clearance on 2020-06-09 under approval number K192033. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip?

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is a medical device that received FDA 510(k) clearance on 2020-06-09. It is manufactured by Bennett Jacoby, Dds, Ms, Inc.. The 510(k) number is K192033.

When was Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip approved by the FDA?

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip received FDA 510(k) clearance on 2020-06-09, under approval number K192033.

What company makes Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip?

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is manufactured by Bennett Jacoby, Dds, Ms, Inc..

What is the FDA product code for 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 product code for Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip is DZI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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