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510(k) K110881

ULTRASONIC SURGICAL UNIT by Dong IL Technology , Ltd. — Product Code DZI

K110881 is an FDA 510(k) premarket notification submitted by Dong IL Technology , Ltd. for the device "ULTRASONIC SURGICAL UNIT". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Dong IL Technology , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
March 30, 2011
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 Dong IL Technology , Ltd.

  • K150076 — Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (June 2, 2015)

Other clearances for product code DZI

  • K253655 — Angled Screwdriver MED (M-SD090) (July 31, 2026)
  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 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)

FDA data resources