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510(k) K964976

FLOSSBRUSH WITH FLUORIDE by Flossbrush Interdental Cleaner and Applicator — Product Code JES

K964976 is an FDA 510(k) premarket notification submitted by Flossbrush Interdental Cleaner and Applicator for the device "FLOSSBRUSH WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
December 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Floss, Dental
Device Class
Class I
Regulation Number
872.6390
Review Panel
DE
Submission Type

Other clearances for product code JES

  • K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (September 24, 2009)
  • K963746 — IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORID (December 12, 1996)
  • K944034 — PERIO-MED DENTAL FLOSS (July 25, 1995)
  • K952091 — VUTLER G.U.M. WITH FLUORIDE (June 28, 1995)
  • K951917 — JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (May 10, 1995)
  • K942689 — RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K944886 — COLGATE PRECISION MINT WZXED DENTAL FLOSS (April 27, 1995)
  • K935440 — JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (February 3, 1994)

FDA data resources