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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 Aug 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 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 26, 1986
Date Received
Aug 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
510(k) Exempt

Other clearances by Teledyne, Inc.

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

Other clearances for product code EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (Dec 11, 2002)
  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (Oct 25, 2000)
  • K983374 — AGATHA-A-H2010 (Dec 23, 1998)
  • K964810 — DERMADAM (Feb 10, 1997)
  • K952234 — BARRIER ALL FILM (Jul 31, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (Sep 9, 1994)
  • K923711 — PERIOFLEX TIP (May 16, 1994)
  • K923937 — HYDRO FLOSS (Feb 25, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (Sep 20, 1993)
  • K923457 — SHOWERFLOSS (Sep 1, 1992)

FDA data resources

Source: FDA 510(k) database entry for K863131. Report a data issue: hello@regdatalab.com.