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510(k) K945248

HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH by Hukuba Dental Corp. — Product Code JEQ

K945248 is an FDA 510(k) premarket notification submitted by Hukuba Dental Corp. for the device "HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Hukuba Dental Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
October 27, 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 Hukuba Dental Corp.

  • K915576 — HUBUKA HYG TOOTHBRUSH (March 4, 1994)

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)
  • K944084 — JENERIC/PENTRON P0WERED TOOTHBRUST (December 20, 1994)

FDA data resources