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510(k) K972436

T1 LINE DENTAL HANDPIECES by Siemens AG — Product Code EFB

K972436 is an FDA 510(k) premarket notification submitted by Siemens AG for the device "T1 LINE DENTAL HANDPIECES". The FDA issued a decision of Substantially Equivalent on September 22, 1997. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Siemens AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1997
Date Received
June 30, 1997
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 Siemens AG

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  • K123375 — SYNGO.VIA (November 20, 2012)
  • K110366 — SYNGO.CT CARDIAC FUNCTION (April 12, 2011)
  • K103360 — DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (December 17, 2010)
  • K081182 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBL (August 8, 2008)
  • K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE (June 8, 2007)
  • K063507 — SYNGO NEURO PBV CT (November 30, 2006)
  • K063373 — FLEX LOOP COIL SET 3T (November 17, 2006)
  • K053024 — SYNGO NEURO DSA CT (November 4, 2005)
  • K050867 — SYNGO BODY PERFUSION-CT (April 14, 2005)

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