Cleared Traditional

K193499 - DigiGuide System

K193499 is an FDA 510(k) clearance for DigiGuide System, manufactured by Protomed, Inc.. The device is a Class 2 Dental device with product code DZJ cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K193499 · Protomed, Inc. · Dental device
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Nov 2020
Decision
323d
Days
Class 2
Risk

K193499 is an FDA 510(k) clearance for the DigiGuide System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by Protomed, Inc. (Westminster, US). The FDA issued a Cleared decision on November 4, 2020 after a review of 323 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 Protomed, Inc. devices

FDA 510(k) Submission Details - K193499

510(k) Number K193499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date November 04, 2020
Days to Decision 323 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
196d slower than avg
Panel avg: 127d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZJ Device Classification - Class 2, Special Controls

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 Peers - DZJ Driver, Wire, And Bone Drill, Manual

All 27
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K193499.
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
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coDiagnostiX
K193301 · Dental Wings GmbH · Jun 2021
VSP System
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MedCAD® AccuPlan® System
K192282 · Medcad · Oct 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · Immersivetouch · Jun 2020
VSP System
K192192 · 3D Systems · Feb 2020