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

K192033 is an FDA 510(k) clearance for Contour P-Insert 90, manufactured by Bennett Jacoby, Dds, Ms, Inc.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K192033 · Bennett Jacoby, Dds, Ms, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.... Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Bennett Jacoby, Dds, Ms, Inc. (Kailua Kona, US). The FDA issued a Cleared decision on June 9, 2020 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bennett Jacoby, Dds, Ms, Inc. devices

FDA 510(k) Submission Details - K192033

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 127d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Contract In-House Counsel & Consultants, LLC (D/B/A FDA Atty
Marc C. Sanchez

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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