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510(k) K023232

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE by Smartpractice — Product Code EFS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2002
Date Received
September 27, 2002
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

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Other clearances for product code EFS

  • 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)
  • K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT (June 16, 1992)