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510(k) K860118

SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 by Northern Electric Co. Div. of Sunbeam Corp. — Product Code EFT

K860118 is an FDA 510(k) premarket notification submitted by Northern Electric Co. Div. of Sunbeam Corp. for the device "SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220". The FDA issued a decision of Substantially Equivalent on April 17, 1986. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. 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
April 17, 1986
Date Received
January 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
Review Panel
DE
Submission Type

Other clearances by Northern Electric Co. Div. of Sunbeam Corp.

  • K851220 — SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (September 17, 1985)
  • K852593 — SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 (July 24, 1985)
  • K852279 — SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 (July 1, 1985)

Other clearances for product code EFT

  • K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (May 23, 2008)
  • K051342 — MEDICAL INTERPOROUS (June 2, 2006)
  • K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (June 16, 2000)
  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)
  • K914257 — DENTURE PRODUCT X (January 13, 1993)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K902838 — DENTURE DYNAMIC'S DENTURE MAGIC (September 6, 1990)
  • K903686 — ARGILITE 4 GOLD ALLOY FOR PORCELAIN (August 29, 1990)
  • K895345 — ORAD TOOTHBRUSH CLEANER (March 7, 1990)

FDA data resources