Data / Medical devices / United States / Genesis Dental Technologies, LLC
Genesis Dental Technologies, LLC: FDA-registered device maker in Elmwood, WI, United States, 1 510(k) clearance
Genesis Dental Technologies, LLC is registered with the FDA (registration 3004961419) in Elmwood, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004961419
- Address
- 200 Main Street, Elmwood, WI, United States, 54740
- Owner or operator
- GENESIS DENTAL TECHNOLOGIES, LLC (9068712)
- Roles
- Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- AQUASEPT, InventDent Root Tip Remover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 1994 | K934436 | SBP DENTAL UNIT | EIA | Substantially Equivalent | Northland Dental Engineering | accessdata.fda.gov |
Compare with other makers
Updated June 2, 1994. 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.