Cleared Traditional

MedCAD AccuPlan System

K223024 · Medcad · Dental
Mar 2023
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K223024 is an FDA 510(k) clearance for the MedCAD AccuPlan System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on March 7, 2023, 159 days after receiving the submission on September 29, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K223024 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date March 07, 2023
Days to Decision 159 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