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510(k) K790723

PROPHYLAXIS CUPS AND POLISHERS by Young Dental Manufacturing Co. 1, LLC — Product Code EHK

K790723 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "PROPHYLAXIS CUPS AND POLISHERS". The FDA issued a decision of Substantially Equivalent on June 15, 1979. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. 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 15, 1979
Date Received
April 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Prophylaxis
Device Class
Class I
Regulation Number
872.6290
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)
  • 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 EHK

  • K953628 — PROPHY ANGLE (September 29, 1995)
  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)
  • K900507 — DISPOSABLE SCREW TYPE PROPHY BRUSH (April 10, 1990)
  • K864059 — DENTAL PROPHY CUPS (VARIOUS TYPES) (November 19, 1986)
  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K770556 — PRO-KUP (March 24, 1977)

FDA data resources