Cleared Traditional

MedCAD? AccuPlan? System

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

About This 510(k) Submission

K192282 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 October 29, 2020, 434 days after receiving the submission on August 22, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K192282 FDA.gov
FDA Decision Cleared 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

Device Classification

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