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510(k) K910832

OXYFRESH OXYCARE 3000 by Oxyfresh — Product Code EFS

K910832 is an FDA 510(k) premarket notification submitted by Oxyfresh for the device "OXYFRESH OXYCARE 3000". The FDA issued a decision of Substantially Equivalent on April 17, 1991. 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
April 17, 1991
Date Received
February 27, 1991
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

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  • 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