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

Q: What is the product code of K240340?

The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.

FDA 510(k) K240340 · Guangdong Jinme Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK240340

Submission

Device name: Surgical Drive System (Model: ES70, ES90, E8)
Applicant: Guangdong Jinme Medical Technology Co., Ltd.
Foshan, CN
Received: February 5, 2024
Decision date: July 18, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DZI – Drill, Bone, Powered
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.4120
Specialty: Dental

Other 510(k)s with product code DZI

510(k)	Device	Applicant	Decision
K253655	Angled Screwdriver MED (M-SD090)DZI · Traditional	W&H Dentalwerk Bürmoos GmbH	07/31/2026SE
K253776	Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional	W&H Dentalwerk Buermoos GmbH	06/18/2026SE
K254163	VarioSurg 4DZI · Traditional	Nakanishi, Inc.	12/23/2025SE
K242432	MT-BoneDZI · Traditional	Mectron S.P.A.	08/19/2024SE
K231087	Guided Surgery KitDZI · Traditional	Implant Direct Sybron Manufacturing, LLC	08/16/2023SE
K192561	Traus SUS20DZI · Traditional	Saeshin Precision Co., Ltd.	07/13/2020SE
K200265	Surgical DrillsDZI · Traditional	Implant Direct Sybron Manufacturing, LLC	06/30/2020SE
K192033	Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional	Bennett Jacoby, Dds, Ms, Inc.	06/09/2020SE
K172137	Piezotome CubeDZI · Traditional	Satelec - Acteon Group	05/03/2018SE
K171326	Piezosurgery WhiteDZI · Traditional	Mectron S.P.A.	04/13/2018SE

More from Mectron S.P.A.

510(k)	Device	Decision
K240337	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional	11/13/2024SE
K170236	Dental Low-speed Turbine HandpieceEFB · Traditional	11/21/2017SE
K170229	Dental High-speed Turbine HandpieceEFB · Traditional	11/08/2017SE

Questions and answers

When was Surgical Drive System (Model: ES70, ES90, E8) cleared by the FDA?

Surgical Drive System (Model: ES70, ES90, E8) (K240340) received a 510(k) decision of Substantially Equivalent on July 18, 2024, 164 days after the submission was received.

What is the product code of K240340?

The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.