Data / Medical devices / Unit, Electrosurgical, And Accessories, Dental
Unit, Electrosurgical, And Accessories, Dental (EKZ): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Unit, Electrosurgical, And Accessories, Dental (product code EKZ, Class 2, 21 CFR 872.4920). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on August 3, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EKZ
- Device class
- 2
- Regulation
- 872.4920
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Taiwan | 1 |
| Japan | 1 |
| France | 1 |
Makers of Unit, Electrosurgical, And Accessories, Dental
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Macan Genesis Manufacturing LLC | Elmwood, WI, United States | Manufacturer | 2 | December 9, 2005 | 0 | 1 | 0 | api.fda.gov |
| Bonart Co. Ltd. | Keelung, Taiwan | Contract manufacturer, Manufacturer | 1 | February 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 1 | October 18, 2007 | 0 | 0 | 0 | api.fda.gov |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 1 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 1 | August 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | June 6, 1995 | 0 | 0 | 0 | api.fda.gov |
| Satelec-Acteon Group | MERIGNAC Gironde, France | Manufacturer | 1 | December 27, 1985 | 0 | 0 | 0 | api.fda.gov |
Updated August 3, 2022. 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.