Data / Medical devices / Device, Electrical Dental Anesthesia
Device, Electrical Dental Anesthesia (LWM): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Device, Electrical Dental Anesthesia (product code LWM, Class U). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 17, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LWM
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
| China | 1 |
Makers of Device, Electrical Dental Anesthesia
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 |
|---|---|---|---|---|---|---|---|---|
| Septodont, Inc | Lancaster, PA, United States | Complaint file establishment, Specification developer | 2 | January 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Electronic Waveform Lab, Inc. | Huntingtn Bch, CA, United States | Specification developer | 1 | April 12, 1988 | 0 | 0 | 0 | api.fda.gov |
| FISHER WALLACE LABORATORIES Inc | Brooklyn, NY, United States | Specification developer | 1 | December 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Satelec-Acteon Group | MERIGNAC Gironde, France | Manufacturer | 1 | June 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Multi-Concept Interconnect Solutions Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 17, 2020. 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.