DistributorLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Handpiece Headquarters with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 20, 2024: HPR Cordless Hygiene Handpiece.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 20, 2024 | HPR Cordless Hygiene HandpieceK243911 · EKX | 510(k) clearances |
| Nov 2, 2023 | BASE290 LED Curing LightK233518 · EBZ | 510(k) clearances |
| Apr 4, 2018 | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not providClass II · Tip of the curing light was too hot causing a heat sensation in the patients. | Device recalls |
| Feb 17, 2015 | Maxima XTEND Handpiece Maintenance SystemK143183 · EFB | 510(k) clearances |
| Oct 23, 2014 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEK141125 · EGS | 510(k) clearances |
| Aug 12, 2010 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENTK100389 · EFB | 510(k) clearances |
| Aug 20, 2009 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATHK092053 · EGS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
