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510(k) K071965

I-SURGE by Satelec — Product Code EFB

K071965 is an FDA 510(k) premarket notification submitted by Satelec for the device "I-SURGE". The FDA issued a decision of Substantially Equivalent on September 10, 2007. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Satelec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2007
Date Received
July 16, 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 Satelec

  • K110379 — AIR-N-GO (December 8, 2011)
  • K100410 — PIEZOELECTRIC SYSTEM (April 28, 2010)
  • K091331 — PIEZOTOME 2 (December 11, 2009)
  • K091252 — IMPLANT CENTER 2 (July 22, 2009)
  • K082116 — HEMOSTASYL PASTE (December 17, 2008)
  • K072181 — MINI LED AUTOFOCUS (September 19, 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 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