Data / Medical devices / Handpiece, Direct Drive, Ac-Powered / United States
FDA-registered makers of Handpiece, Direct Drive, Ac-Powered in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Handpiece, Direct Drive, Ac-Powered (product code EKX). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Handpiece, Direct Drive, Ac-Powered
- Product code
- EKX
- Country
- United States
Makers of Handpiece, Direct Drive, Ac-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aseptico, Inc. | Woodinville, WA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 5 | May 28, 2015 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Specification developer | 2 | August 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Manufacturer | 1 | September 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Handpiece Headquarters - HPR Inc. | Placentia, CA, United States | Specification developer | 1 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Perimetrics, Inc | Santa Ana, CA, United States | Complaint file establishment, Manufacturer | 1 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 1 | February 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Specification developer | 1 | August 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Angstrom MFG., Inc. | Sainte Genevieve, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.