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510(k) K060274

PIEZOTOME by Satelec — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2006
Date Received
February 2, 2006
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)
  • K091331 — PIEZOTOME 2 (December 11, 2009)
  • 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)
  • K053328 — BIOSPLINT SPLINTING RIBBON (January 25, 2006)
  • K050895 — SURPASSON P5 NEWTRON (April 20, 2005)

Other clearances for product code DZI

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  • 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)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)