Handpiece Headquarters

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0797-2019Class IIHenry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use iApril 4, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K243911HPR Cordless Hygiene HandpieceDecember 20, 2024
K233518BASE290 LED Curing LightNovember 2, 2023
K143183Maxima XTEND Handpiece Maintenance SystemFebruary 17, 2015
K141125U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEOctober 23, 2014
K100389HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENTAugust 12, 2010
K092053MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATHAugust 20, 2009