Home / 510(k) Clearances / K151248

510(k) K151248

PIEZOSURGERY WHITE by Mectron S.P.A. — Product Code DZI

K151248 is an FDA 510(k) premarket notification submitted by Mectron S.P.A. for the device "PIEZOSURGERY WHITE". The FDA issued a decision of Substantially Equivalent on September 4, 2015. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Mectron S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2015
Date Received
May 11, 2015
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.

  • K251425 — turbodent touch (May 9, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K231391 — Combi Touch (May 15, 2023)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • 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

  • 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)
  • K171326 — Piezosurgery White (April 13, 2018)

FDA data resources