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510(k) K943157

ORAL-B ULTRAFLOSS WITH FLLUORIDE by Oral-B Laboratories — Product Code JES

K943157 is an FDA 510(k) premarket notification submitted by Oral-B Laboratories for the device "ORAL-B ULTRAFLOSS WITH FLLUORIDE". The FDA issued a decision of Substantially Equivalent on April 27, 1995. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Oral-B Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
July 1, 1994
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 Oral-B Laboratories

  • K942633 — ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (April 27, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K932990 — ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP (September 29, 1993)
  • K925409 — ORAL-B DENTAL FLOSS WITH FLUORIDE (January 28, 1993)
  • K925408 — ORAL-B DENTAL TAPE WITH FLUORIDE (January 28, 1993)
  • K913603 — FIBRETWINS (September 30, 1991)
  • K883024 — ORAL-B FLOSSERS (August 26, 1988)

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)
  • K935440 — JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (February 3, 1994)

FDA data resources