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510(k) K001493

DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 by Air Force, Inc. — Product Code EFS

K001493 is an FDA 510(k) premarket notification submitted by Air Force, Inc. for the device "DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001". The FDA issued a decision of Substantially Equivalent on October 25, 2000. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
May 12, 2000
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 for product code EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)
  • 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)
  • K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT (June 16, 1992)

FDA data resources