Cleared Traditional

KLS Martin Individual Patient Solutions (IPS) Planning System

K182789 · KLS-Martin L.P. · Dental
Mar 2019
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K182789 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 11, 2019, 161 days after receiving the submission on October 1, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K182789 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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