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510(k) K931380

WATER PIK PLUS PLAQUE CONTROL SYSTEM by Teledyne Water Pik — Product Code EFS

K931380 is an FDA 510(k) premarket notification submitted by Teledyne Water Pik for the device "WATER PIK PLUS PLAQUE CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 1993. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Teledyne Water Pik has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
March 18, 1993
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 Teledyne Water Pik

  • K970594 — KALGINATE IMPRESSION MATERIAL (March 31, 1997)
  • K952422 — ELASTIC IMPRESSION CREAM (August 29, 1995)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K940288 — WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT (May 26, 1994)
  • K905188 — PERIO PIK (February 15, 1991)
  • K900547 — WATER PIK(R) W/ADD'L CLAIMS (June 15, 1990)
  • K895259 — PIK POCKET(R), MODEL PP-3 (November 1, 1989)
  • K894015 — WATER PIK(R) (August 28, 1989)

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)
  • K923457 — SHOWERFLOSS (September 1, 1992)
  • K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT (June 16, 1992)

FDA data resources