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510(k) K912430

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

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)

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  • K944034 — PERIO-MED DENTAL FLOSS (July 25, 1995)
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  • K944886 — COLGATE PRECISION MINT WZXED DENTAL FLOSS (April 27, 1995)
  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K943157 — ORAL-B ULTRAFLOSS WITH FLLUORIDE (April 27, 1995)
  • K942689 — RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (April 27, 1995)