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510(k) K852593

SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 by Northern Electric Co. Div. of Sunbeam Corp. — Product Code EFS

K852593 is an FDA 510(k) premarket notification submitted by Northern Electric Co. Div. of Sunbeam Corp. for the device "SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273". The FDA issued a decision of Substantially Equivalent on July 24, 1985. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. 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 24, 1985
Date Received
June 19, 1985
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

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)
  • K852279 — SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 (July 1, 1985)

Other clearances for product code EFS

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

FDA data resources