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510(k) K240340

Surgical Drive System (Model: ES70, ES90, E8) by Guangdong Jinme Medical Technology Co., Ltd. — Product Code DZI

K240340 is an FDA 510(k) premarket notification submitted by Guangdong Jinme Medical Technology Co., Ltd. for the device "Surgical Drive System (Model: ES70, ES90, E8)". The FDA issued a decision of Substantially Equivalent on July 18, 2024. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Guangdong Jinme Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
February 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Guangdong Jinme Medical Technology Co., Ltd.

  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K170236 — Dental Low-speed Turbine Handpiece (November 21, 2017)
  • K170229 — Dental High-speed Turbine Handpiece (November 8, 2017)

Other clearances for product code DZI

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)

FDA data resources