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510(k) K171326

Piezosurgery White by Mectron S.P.A. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2018
Date Received
May 5, 2017
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 Mectron S.P.A.

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  • K242432 — MT-Bone (August 19, 2024)
  • K231391 — Combi Touch (May 15, 2023)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K151248 — PIEZOSURGERY WHITE (September 4, 2015)
  • K151023 — COMPACT PIEZO LED (August 5, 2015)
  • K140965 — MULTIPIEZO PRO, MULTIPIEZO (August 20, 2014)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K122322 — PIEZOSURGERY TOUCH (December 6, 2012)

Other clearances for product code DZI

  • 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)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K152125 — Oral Surgery System and Accessories (August 15, 2016)