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510(k) K100410

PIEZOELECTRIC SYSTEM by Satelec — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2010
Date Received
February 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Satelec

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  • 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 JDX

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  • K172464 — XD880A Ultrasonic Osteotomy Surgical System (April 24, 2018)
  • K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece (May 19, 2017)
  • K153743 — PIEZOSURGERY PLUS (May 25, 2016)
  • K132848 — PIEZOSURGERY FLEX (November 29, 2013)
  • K093805 — OSCAR 3 (February 19, 2010)
  • K083284 — PIEZOSURGERY MEDICAL (April 8, 2009)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (December 19, 2007)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)