Cleared Traditional

Surgical Drive System (Model: ES70, ES90, E8)

K240340 · Guangdong Jinme Medical Technology Co., Ltd. · Dental
Jul 2024
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K240340 is an FDA 510(k) clearance for the Surgical Drive System (Model: ES70, ES90, E8), a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on July 18, 2024, 164 days after receiving the submission on February 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K240340 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2024
Decision Date July 18, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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