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510(k) K172137

PIEZOTOME CUBE by Satelec - Acteon Group — Product Code DZI

K172137 is an FDA 510(k) premarket notification submitted by Satelec - Acteon Group for the device "PIEZOTOME CUBE". The FDA issued a decision of Substantially Equivalent on May 3, 2018. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Satelec - Acteon Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2018
Date Received
July 17, 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 Satelec - Acteon Group

  • K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CO (March 11, 2024)
  • K131906 — SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANW (April 11, 2014)
  • K132322 — NEWTRON P5 XS B.LED (March 11, 2014)
  • K132267 — NEWTRON P5, NEWTRON P5 B.LED (March 10, 2014)
  • K131151 — ENDOCENTER (January 16, 2014)
  • K131997 — NEWTRON BOOSTER (November 26, 2013)
  • K113430 — PROULTRA PIEZO ULTRASONIC (February 23, 2012)
  • K111623 — I-ENDO DUAL (January 10, 2012)
  • K072030 — IMPLANT CENTER (November 19, 2007)
  • K071424 — PMAX NEWTRON XS (August 24, 2007)

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)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)

FDA data resources