Cleared Traditional

K192033 - Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (FDA 510(k) Clearance)

K192033 · Bennett Jacoby, Dds, Ms, Inc. · Dental device
Jun 2020
Decision
315d
Days
Class 2
Risk

K192033 is an FDA 510(k) clearance for the Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).

Submitted by Bennett Jacoby, Dds, Ms, Inc. (Kailua Kona, US). The FDA issued a Cleared decision on June 9, 2020, 315 days after receiving the submission on July 30, 2019.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K192033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2019
Decision Date June 09, 2020
Days to Decision 315 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI - Drill, Bone, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.4120