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510(k) K131319

T1/T2/T3 TURBINE FAMILY by Sirona Dental Systems GmbH — Product Code EFB

K131319 is an FDA 510(k) premarket notification submitted by Sirona Dental Systems GmbH for the device "T1/T2/T3 TURBINE FAMILY". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Sirona Dental Systems GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2014
Date Received
May 7, 2013
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 Sirona Dental Systems GmbH

  • K160099 — CEREC SpeedGlaze (June 2, 2016)
  • K151045 — TENEO Dental Treatment Unit and Accessories (July 24, 2015)
  • K150909 — INTEGO Family and Accesories (July 17, 2015)
  • K150750 — Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (July 2, 2015)
  • K150217 — ORTHOPHOS SL (May 8, 2015)
  • K132773 — SIDEXIS 4 (December 11, 2013)
  • K123664 — INCORIS ZI (April 8, 2013)
  • K123952 — CEREC BLOCS C IN (March 20, 2013)
  • K123070 — GALILEOS FAMILY (March 15, 2013)
  • K123545 — INCORIS TZI (February 1, 2013)

Other clearances for product code EFB

  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (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