Home / 510(k) Clearances / K921601

510(k) K921601

ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE by Ultradent Products, Inc. — Product Code JES

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1992
Date Received
April 3, 1992
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 Ultradent Products, Inc.

  • K240743 — Peak Universal Bond (March 20, 2024)
  • K240694 — FORMA Composite (Shade A3D) (March 15, 2024)
  • K221909 — J-Temp (July 1, 2022)
  • K220471 — VALO X, VALO X Accessory Lenses (February 22, 2022)
  • K211905 — UltraCal XS (October 13, 2021)
  • K211237 — UltraTemp Rez II (July 13, 2021)
  • K210550 — VALO Grand Corded and Accessory Lenses (March 1, 2021)
  • K190627 — VALO Grand Corded (April 29, 2019)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K160551 — VALO Grand (July 13, 2016)

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)
  • 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)