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510(k) K111290

PIEZO BONE SURGERY by Guilin Woodpecker Medical Instrument Co., Ltd. — Product Code DZI

K111290 is an FDA 510(k) premarket notification submitted by Guilin Woodpecker Medical Instrument Co., Ltd. for the device "PIEZO BONE SURGERY". The FDA issued a decision of Substantially Equivalent on November 18, 2011. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Guilin Woodpecker Medical Instrument Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
May 6, 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 Guilin Woodpecker Medical Instrument Co., Ltd.

  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K222569 — Ai Ray Dental X-Ray Device (November 23, 2022)
  • K211358 — Implanter incl. Accessories (November 21, 2022)
  • K221548 — Dental Air Polishing Handpiece (September 28, 2022)
  • K210367 — D-Laser Blue, D-Laser 16 (March 10, 2022)
  • K203706 — Dental Electric Motor (January 13, 2022)
  • K211531 — Cordless Prophy System, Model: i-Polish (December 17, 2021)
  • K203615 — Dental Scaler and Air Polisher (December 10, 2021)
  • K212080 — Imaging Plate Scanner, i-Scan (September 27, 2021)
  • K203320 — Endo Motor (May 10, 2021)

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