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510(k) K903284

YOUNG PROPHY SYSTEM, PS UNIT by Young Dental Manufacturing Co. 1, LLC — Product Code KOJ

K903284 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "YOUNG PROPHY SYSTEM, PS UNIT". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1990
Date Received
July 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
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)
  • K875340 — JETPOLISHER(TM) (June 10, 1988)
  • K875339 — JETPOLISHER AIRPOLISHING POWDER (April 18, 1988)
  • K821484 — DAWN LOW SPEED HANDPIECE SYSTEM (June 9, 1982)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)
  • K790722 — PROPHYLAXIS ANGLE (June 15, 1979)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)

FDA data resources