Cleared Traditional

MedCAD? AccuPlate? 3DTi Patient-Specific Plating System

K230398 · Medcad · Dental
Sep 2023
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K230398 is an FDA 510(k) clearance for the MedCAD? AccuPlate? 3DTi Patient-Specific Plating System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Medcad (Dallas, US). The FDA issued a Cleared decision on September 26, 2023, 222 days after receiving the submission on February 16, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K230398 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2023
Decision Date September 26, 2023
Days to Decision 222 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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