Home / 510(k) Clearances / K944084

510(k) K944084

JENERIC/PENTRON P0WERED TOOTHBRUST by Jeneric/Pentron, Inc. — Product Code JEQ

K944084 is an FDA 510(k) premarket notification submitted by Jeneric/Pentron, Inc. for the device "JENERIC/PENTRON P0WERED TOOTHBRUST". The FDA issued a decision of Substantially Equivalent on December 20, 1994. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Jeneric/Pentron, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1994
Date Received
August 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Powered
Device Class
Class I
Regulation Number
872.6865
Review Panel
DE
Submission Type

Other clearances by Jeneric/Pentron, Inc.

  • K020499 — BOND-3 ADHESIVE (April 22, 2002)
  • K013543 — BOND-1 C & B (February 22, 2002)
  • K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (February 14, 2002)
  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K011748 — FIRST FILL R.C.S. (August 3, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

Other clearances for product code JEQ

  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
  • K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
  • K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (July 2, 2004)
  • K022900 — BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (November 14, 2002)
  • K012914 — SONICWAVE SONIC PLAQUE REMOVER (October 1, 2001)
  • K970381 — POWERED TOOTHBRUSH (April 18, 1997)
  • K943942 — TRAV-LER KIT (March 8, 1995)
  • K945248 — HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (January 26, 1995)

FDA data resources