Cleared Traditional

K192033 - Contour P-Insert 90

K192033 is the FDA 510(k) clearance for Contour P-Insert 90 by Bennett Jacoby, Dds, Ms, Inc.. It is a Class 2 Dental device (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)
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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

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
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.

Device Classification

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.

Regulatory Peers - DZI Drill, Bone, Powered

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