Manufacturer registered with FDA
Macan Genesis Manufacturing LLC
Elmwood, WI, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Macan Genesis Manufacturing LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Electrosurgical Unit and AccessoriesEKZ · Class 2 | — | Maker | MACAN Model MC-4A Dental Electrosurgery UnitRadiosurge MC6A | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Macan Genesis Manufacturing LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Macan Engineering Co. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Dec 2005 | K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | Macan Engineering Co. | EKZ Dental Electrosurgical Unit and Accessories |
| 23 May 2005 | K050735 | MC6A | Macan Engineering Co. | EKZ Dental Electrosurgical Unit and Accessories |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MACAN GENESIS MANUFACTURING LLCFDA reg. 1418975 | Elmwood, WI, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089573). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.