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510(k) K904850

DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 by Micro Motors, Inc. — Product Code EFS

K904850 is an FDA 510(k) premarket notification submitted by Micro Motors, Inc. for the device "DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555". The FDA issued a decision of Substantially Equivalent on January 25, 1991. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Micro Motors, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
October 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
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)
  • K911068 — 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM (May 15, 1991)
  • K903298 — DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP (April 16, 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 EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)
  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (October 25, 2000)
  • K983374 — AGATHA-A-H2010 (December 23, 1998)
  • K964810 — DERMADAM (February 10, 1997)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K923711 — PERIOFLEX TIP (May 16, 1994)
  • K923937 — HYDRO FLOSS (February 25, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K923457 — SHOWERFLOSS (September 1, 1992)

FDA data resources