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510(k) K852279

SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 by Northern Electric Co. Div. of Sunbeam Corp. — Product Code JEQ

K852279 is an FDA 510(k) premarket notification submitted by Northern Electric Co. Div. of Sunbeam Corp. for the device "SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Northern Electric Co. Div. of Sunbeam Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
May 29, 1985
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 Northern Electric Co. Div. of Sunbeam Corp.

  • K860118 — SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 (April 17, 1986)
  • K851220 — SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (September 17, 1985)
  • K852593 — SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 (July 24, 1985)

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