Manufacturer registered with FDA
Valensil
Avon, OH, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Valensil currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intranasal Expiratory Resistance Valve for Obstructive Sleep ApneaOHP · Class 2 | — | Maker | ULTepap | 2020 |
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
Valensil 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: Bryggs Medical, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Feb 2020 | K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | OHP Intranasal Expiratory Resistance Valve for Obstructive Sleep Apnea |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VALENSILFDA reg. 3016609920 | Avon, OH, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062875). 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.