Company ยท US
Handpiece Headquarters
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2024 | K243911 | HPR Cordless Hygiene Handpiece Handpiece Headquarters | EKX |
| Nov 2, 2023 | K233518 | BASE290 LED Curing Light Handpiece Headquarters | EBZ |
| Feb 17, 2015 | K143183 | Maxima XTEND Handpiece Maintenance System Handpiece Headquarters | EFB |
| Oct 23, 2014 | K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE Handpiece Headquarters | EGS |
| Aug 12, 2010 | K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT Handpiece Headquarters | EFB |
| Aug 20, 2009 | K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH Handpiece Headquarters | EGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2018 | Handpiece Headquarters Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Sc Open, Classified |
EBZ | K060646 |