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510(k) K863131

PIK POCKET (IRRIGATING TIP) by Teledyne, Inc. — Product Code EFS

K863131 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "PIK POCKET (IRRIGATING TIP)". The FDA issued a decision of Substantially Equivalent on August 26, 1986. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Teledyne, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1986
Date Received
August 15, 1986
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, Inc.

  • K871828 — TED MODEL 760 (February 4, 1988)
  • K862695 — FLUOR-ETCH GEL ETCHANT (July 31, 1986)
  • K854817 — INSTAPURE (February 28, 1986)
  • K840721 — PERIO PIK (April 25, 1984)
  • K810864 — WATER PIK ORAL HYGIENE CENTER (April 21, 1981)
  • K810805 — WATER PIK AUTOMATIC TOOTHBRUSH (April 14, 1981)
  • K801593 — LEBODY BY WATER PIK (August 20, 1980)
  • K800919 — ORAVIEW BY WATER PIK (May 8, 1980)
  • K800448 — WATER PIK TRAVELER, MODEL 79 (March 5, 1980)

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