Home / 510(k) Clearances / K781520

510(k) K781520

RUBBER DAM HOLDER by Young Dental Manufacturing Co. 1, LLC — Product Code EJE

K781520 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "RUBBER DAM HOLDER". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code EJE (Frame, Rubber Dam), a Class I device regulated under 21 CFR 872.6300. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Rubber Dam
Device Class
Class I
Regulation Number
872.6300
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)
  • K790723 — PROPHYLAXIS CUPS AND POLISHERS (June 15, 1979)

Other clearances for product code EJE

  • K780746 — HYGIENIC RUBBER DAM FRAME (May 12, 1978)
  • K770117 — HYGIENIC 5 & 6 RUBBER DAM FRAME (January 28, 1977)

FDA data resources