Young INFINITY Cordless Handpiece System— 510(k) K171377

Name: FDA 510(k) clearance K171377
Creator: U.S. Food and Drug Administration
Published: 2018-08-20

Substantially Equivalent

Young Dental Manufacturing Co. 1, LLC

FDA 510(k) clearance K171377 for Young INFINITY Cordless Handpiece System, Substantially Equivalent on 2018-08-20. Applicant: Young Dental Manufacturing Co. 1, LLC. Device class: 1.

Clearance details

Applicant: Young Dental Manufacturing Co. 1, LLC
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2017-05-10
Decision date: 2018-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Earth City, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKX

view all

K261987 — Reusable SmartPeg2026-09-08
K252223 — Alpha Endo Handpiece (Alpha Endo)2025-10-16
K251597 — InnerView System2025-09-18
K243692 — EnDrive (EnDriveUS)2025-08-22
K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)2025-04-24

More clearances from Young Dental Manufacturing Co. 1, LLC

view all

K241041 — Silver Fluoride Hypersensitivity Varnish2025-02-28
K201127 — DEFEND Ear-loop Face Masks2021-04-14
K153334 — Oral-B 5% Sodium Fluoride Varnish2016-05-20
K932255 — YOUNG D'GRANULATOR1994-04-15
K903284 — YOUNG PROPHY SYSTEM, PS UNIT1990-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.