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510(k) K790113

MIDWEST 1000 by Midwest — Product Code EFB

K790113 is an FDA 510(k) premarket notification submitted by Midwest for the device "MIDWEST 1000". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Midwest has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1979
Date Received
January 19, 1979
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 Midwest

  • K863677 — TRADITION HIGH SPEED HANDPIECE (October 6, 1986)
  • K850344 — AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG (March 25, 1985)
  • K792445 — MW STRAIGHT ATTACHMENT (December 6, 1979)
  • K792302 — LS-100 (November 27, 1979)
  • K792303 — MW 8000-I (November 27, 1979)
  • K792304 — MW-8000 (November 27, 1979)
  • K791771 — ORALUMINATOR III AUTO-LIGHT (November 20, 1979)
  • K791733 — LIGHT-PAK (October 23, 1979)
  • K781878 — LIGHT, INSIDE (December 29, 1978)
  • K760795 — FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. (October 20, 1976)

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