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510(k) K911068

29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM by Micro Motors, Inc. — Product Code EFB

K911068 is an FDA 510(k) premarket notification submitted by Micro Motors, Inc. for the device "29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Micro Motors, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
March 11, 1991
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 Micro Motors, Inc.

  • K000120 — PRO-TORQ (February 3, 2000)
  • K991283 — DYNA TORQ TORQUE WRENCH, TORQUE WRENCH (August 18, 1999)
  • K963843 — ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT (March 31, 1997)
  • K970002 — STERILE WATER PUMP (March 5, 1997)
  • K942380 — MICRO ICS SONIC SCALER (August 7, 1995)
  • K935676 — MICRO RSH HIGH SPEED HANDPIECE (March 31, 1995)
  • K903298 — DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP (April 16, 1991)
  • K904850 — DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 (January 25, 1991)
  • K896878 — HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) (March 8, 1990)
  • K896877 — DENTAL AIR MOTORS (SEVERAL MODELS) (March 7, 1990)

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