Cleared Traditional

K182789 - KLS Martin Individual Patient Solutions...

K182789 is the FDA 510(k) clearance for KLS Martin Individual Patient Solutions... by KLS-Martin L.P.. It is a Class 2 Dental device (product code DZJ) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K182789 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
161d
Days
Class 2
Risk

K182789 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System. Classified as Driver, Wire, And Bone Drill, Manual (product code DZJ), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 11, 2019 after a review of 161 days - an extended review cycle.

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. Standard predicate reliance. 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K182789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2018
Decision Date March 11, 2019
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
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 Peers - DZJ Driver, Wire, And Bone Drill, Manual

All 21
Devices cleared under the same product code (DZJ) and FDA review panel - the closest regulatory comparables to K182789.
MedCAD® AccuPlan® System
K192282 · Medcad · Oct 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · Immersivetouch · Jun 2020
VSP System
K192192 · 3D Systems · Feb 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · KLS-Martin L.P. · Sep 2018
PROPEL Device
K172164 · Propel Orthodontics, LLC · Jan 2018
Dental Bone Cutting Instruments
K150796 · Synthes USA Products, LLC · Jun 2015