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510(k) K090937

E-STATIS 40 SYSTEM by Scican , Ltd. — Product Code EBW

K090937 is an FDA 510(k) premarket notification submitted by Scican , Ltd. for the device "E-STATIS 40 SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 2009. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Scican , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2009
Date Received
April 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Scican , Ltd.

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  • K192910 — STATClave G4 Chamber Autoclave (June 19, 2020)
  • K190062 — STATCLAVE G4 Chamber Autoclave (July 26, 2019)
  • K172292 — SALUS - Hygiene Instrument Reprocessing Container (November 24, 2017)
  • K132356 — SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (January 31, 2014)
  • K112872 — STATIM 2000 G4 CASSETTE (July 10, 2012)
  • K090265 — BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (May 15, 2009)
  • K073319 — STATMATIC 31 HANDPIECE MAINTENANCE UNIT (February 4, 2008)
  • K072466 — STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MO (December 19, 2007)

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  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)

FDA data resources