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510(k) K943182

ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR by Oral-B Laboratories — Product Code EFS

K943182 is an FDA 510(k) premarket notification submitted by Oral-B Laboratories for the device "ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR". The FDA issued a decision of Substantially Equivalent on September 9, 1994. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Oral-B Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
July 1, 1994
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 Oral-B Laboratories

  • K942633 — ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (April 27, 1995)
  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K932990 — ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP (September 29, 1993)
  • K925409 — ORAL-B DENTAL FLOSS WITH FLUORIDE (January 28, 1993)
  • K925408 — ORAL-B DENTAL TAPE WITH FLUORIDE (January 28, 1993)
  • K913603 — FIBRETWINS (September 30, 1991)
  • K883024 — ORAL-B FLOSSERS (August 26, 1988)

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)
  • 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