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510(k) K073319

STATMATIC 31 HANDPIECE MAINTENANCE UNIT by Scican , Ltd. — Product Code EFB

K073319 is an FDA 510(k) premarket notification submitted by Scican , Ltd. for the device "STATMATIC 31 HANDPIECE MAINTENANCE UNIT". The FDA issued a decision of Substantially Equivalent on February 4, 2008. The device falls under product code EFB (Handpiece, Air-Powered, Dental), 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
February 4, 2008
Date Received
November 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Scican , Ltd.

  • K214057 — STATIM 6000B Vacuum Autoclave (March 31, 2022)
  • K210326 — Bravo G4 Chamber Autoclave (July 1, 2021)
  • 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)
  • K090937 — E-STATIS 40 SYSTEM (July 24, 2009)
  • K090265 — BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (May 15, 2009)
  • K072466 — STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MO (December 19, 2007)

Other clearances for product code EFB

  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)

FDA data resources