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510(k) K171377

Young INFINITY Cordless Handpiece System by Young Dental Manufacturing Co. 1, LLC — Product Code EKX

K171377 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "Young INFINITY Cordless Handpiece System". The FDA issued a decision of Substantially Equivalent on August 20, 2018. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2018
Date Received
May 10, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
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)
  • 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)
  • K790722 — PROPHYLAXIS ANGLE (June 15, 1979)

Other clearances for product code EKX

  • K252223 — Alpha Endo Handpiece (Alpha Endo) (October 16, 2025)
  • K251597 — InnerView System (September 18, 2025)
  • K243692 — EnDrive (EnDriveUS) (August 22, 2025)
  • K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (April 24, 2025)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K222688 — The Trust (August 9, 2024)
  • K233865 — X-Smart Pro; X-Smart Pro+ (July 24, 2024)
  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)

FDA data resources