FDA 510(k) clearance · back to tracker

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

Guangdong Jinme Medical Technology Co., Ltd. cleared K240340 on 2024-07-18, decision: substantially equivalent

K-number

K240340

Sponsor

Guangdong Jinme Medical Technology Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-07-18

Product code

DZI

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.4120

Official FDA record

Open K240340on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.