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510(k) K113152

ULTRASONIC SURGERY MACHINE by Dmetec.Co., Ltd. — Product Code DZI

K113152 is an FDA 510(k) premarket notification submitted by Dmetec.Co., Ltd. for the device "ULTRASONIC SURGERY MACHINE". The FDA issued a decision of Substantially Equivalent on June 14, 2012. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Dmetec.Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2012
Date Received
October 25, 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 Dmetec.Co., Ltd.

  • K170104 — COMPACT S, COMPACT S (LED) (December 27, 2017)
  • K121620 — ULTRASONIC SURGERY (December 11, 2012)
  • K060171 — CLEANSE S+ ULTRASONIC SCALER (March 29, 2006)
  • K051571 — SKYLIGHT LED CURING LIGHT (July 19, 2005)

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