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510(k) K780929

COTTON TIPPED POINT by Young Dental Manufacturing Co. 1, LLC — Product Code KXF

K780929 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "COTTON TIPPED POINT". The FDA issued a decision of Substantially Equivalent on June 30, 1978. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1978
Date Received
June 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

Other clearances by Young Dental Manufacturing Co. 1, LLC

  • K241041 — Silver Fluoride Hypersensitivity Varnish (February 28, 2025)
  • K201127 — DEFEND Ear-loop Face Masks (April 14, 2021)
  • K171377 — Young INFINITY Cordless Handpiece System (August 20, 2018)
  • K153334 — Oral-B 5% Sodium Fluoride Varnish (May 20, 2016)
  • K932255 — YOUNG D'GRANULATOR (April 15, 1994)
  • K903284 — YOUNG PROPHY SYSTEM, PS UNIT (December 17, 1990)
  • K875340 — JETPOLISHER(TM) (June 10, 1988)
  • K875339 — JETPOLISHER AIRPOLISHING POWDER (April 18, 1988)
  • K821484 — DAWN LOW SPEED HANDPIECE SYSTEM (June 9, 1982)
  • K790722 — PROPHYLAXIS ANGLE (June 15, 1979)

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K063160 — ALLERGEAZE PATCH TEST CHAMBERS (December 22, 2006)
  • K013820 — FINN CHAMBER (R) (January 30, 2002)
  • K992553 — IQ CHAMBERS (April 12, 2000)
  • K870762 — EAR APPLICATOR, CATALOG NO. 2229 (March 6, 1987)
  • K843720 — COTTON TIPPED APPLICATORS, SINGLE (October 4, 1984)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K813506 — FARRORS TMJ CASSETTE HOLDER (January 29, 1982)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)

FDA data resources