Handpiece Headquarters
FDA Regulatory Profile
Handpiece Headquarters appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0797-2019, Class II) was initiated on April 4, 2018. Its most recent 510(k) clearance was granted on December 20, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0797-2019 | Class II | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use i | April 4, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243911 | HPR Cordless Hygiene Handpiece | December 20, 2024 |
| K233518 | BASE290 LED Curing Light | November 2, 2023 |
| K143183 | Maxima XTEND Handpiece Maintenance System | February 17, 2015 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | October 23, 2014 |
| K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT | August 12, 2010 |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | August 20, 2009 |