Manufacturer registered with FDA
Ergonomic Products, Inc.
Fall River, MA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 12014–2014
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Ergonomic Products, Inc. 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 | Ergonomic Products, Inc. | 1 clearances | 2014–2014 | Below |
| Canada | Health Canada | Registration holder | ERGONOMIC PRODUCTS, INC. | 4 | 2012–2012 | 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 Ergonomic Products, Inc. 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 Operating LightEAZ · Class 1 | Dental operating lights | Maker | AuroraFastTrack | 2018 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Ergonomic Products Workstation | 2014 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Ergonomic Products 3 Series Dental Chair | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ERGONOMIC PRODUCTS, INC.FDA reg. 3004064895 | Fall River, MA, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046842). 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.