Manufacturer registered with FDA
Bioresearch
Mequon, WI, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 21991–1995
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Bioresearch as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bioresearch | 2 clearances | 1991–1995 | Below |
| South Korea | MFDS | Manufacturer | BioRESEARCH Associates, Inc.BioResearch Associates, Inc. · BioResearch,Inc. | 3 | 2001–2015 | Pure Global AI |
| Canada | Health Canada | Registration holder | BIORESEARCH ASSOCIATES, INC | 2 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bioresearch 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 Sonography Device for Monitoring Jaw SoundsNFQ · Class 1 | — | Maker | BioJVABioJVA WirelessBioPAK | 2008 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Maker | BioPAKJT-3 | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Bioresearch as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIO-RESEARCH ASSOCIATES, INC.FDA reg. 2183552 | Mequon, WI, United States | Complaint file establishment, Manufacturer |
Other names on FDA records
BioResearch Associates, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2183552). 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.