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510(k) K912430

DENTAL FLOSS by Westone Products , Ltd. — Product Code JES

K912430 is an FDA 510(k) premarket notification submitted by Westone Products , Ltd. for the device "DENTAL FLOSS". The FDA issued a decision of Substantially Equivalent on September 30, 1991. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Westone Products , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1991
Date Received
May 31, 1991
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 by Westone Products , Ltd.

  • K913087 — DENTAL FLOSS (September 30, 1991)
  • K864832 — DENTAL FLOSS (February 10, 1987)

Other clearances for product code JES

  • K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (September 24, 2009)
  • K964976 — FLOSSBRUSH WITH FLUORIDE (May 6, 1997)
  • 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)
  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K944886 — COLGATE PRECISION MINT WZXED DENTAL FLOSS (April 27, 1995)
  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)

FDA data resources