Manufacturer registered with FDA
Tess Oral Health
Eau Claire, WI, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Tess Oral Health 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 | Tess Oral Health | 7 device types | — | Below |
| Colombia | INVIMA | Manufacturer | TESS ORAL HEALTH | 1 | — | 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 Tess Oral Health currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Tess Oral Health Mouth Mirror | 2011 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Boie USA ToothbrushTess Oral Health Concept ToothbrushTess Oral Health Easy Braces ToothbrushTess Oral Health Signature ToothbrushTess Oral Health Toothbrush | 2007 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Tess Oral Health Relief Wax | 2011 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Implant-Prophy+ | 2009 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Proxi-FlossTess Oral Health Proxi-FlossTess Oral Health Waxed Floss | 2007 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Proxi-Stik | 2009 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | Proxi-Tip | 2009 |
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 |
|---|---|---|
| Tess Oral Health LLCFDA reg. 3004789183 | EAU CLAIRE, WI, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9105683). 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.