Cleared Traditional

MedCAD® AccuPlan® System (K192282) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192282 · Medcad · Dental device
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Oct 2020
Decision
434d
Days
Class 2
Risk

K192282 is an FDA 510(k) clearance for the MedCAD® AccuPlan® System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on October 29, 2020 after a review of 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Medcad devices

Submission Details

510(k) Number K192282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date October 29, 2020
Days to Decision 434 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
307d slower than avg
Panel avg: 127d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZJ Driver, Wire, And Bone Drill, Manual
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

Secure BioMed Evaluations
Linda Braddon

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 - DZJ Driver, Wire, And Bone Drill, Manual

All 19
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K192282.
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K193301 · Dental Wings GmbH · Jun 2021
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DigiGuide System
K193499 · Protomed, Inc. · Nov 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · Immersivetouch · Jun 2020
VSP System
K192192 · 3D Systems · Feb 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · KLS-Martin L.P. · Mar 2019