Manufacturer registered with FDA
American Sleep Dentistry
Cedar City, UT, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12017–2017
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What American Sleep Dentistry currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | American Sleep Dentistry Oral ApplianceASD Oral ApplianceASD Oral Appliances | 2015 |
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
American Sleep Dentistry 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: American Sleep Association (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Oct 2013 | K130504 | ASA ORAL APPLIANCES | American Sleep Association | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AMERICAN SLEEP DENTISTRYFDA reg. 3008313791 | Cedar City, UT, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050648). 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.