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510(k) K091331

PIEZOTOME 2 by Satelec — Product Code DZI

K091331 is an FDA 510(k) premarket notification submitted by Satelec for the device "PIEZOTOME 2". The FDA issued a decision of Substantially Equivalent on December 11, 2009. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Satelec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2009
Date Received
May 5, 2009
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

  • K110379 — AIR-N-GO (December 8, 2011)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K091252 — IMPLANT CENTER 2 (July 22, 2009)
  • K082116 — HEMOSTASYL PASTE (December 17, 2008)
  • K072181 — MINI LED AUTOFOCUS (September 19, 2007)
  • K071965 — I-SURGE (September 10, 2007)
  • K060275 — PIEZOTOME (May 3, 2006)
  • K060274 — PIEZOTOME (May 1, 2006)
  • K053328 — BIOSPLINT SPLINTING RIBBON (January 25, 2006)
  • K050895 — SURPASSON P5 NEWTRON (April 20, 2005)

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