Data / Medical devices / United States / American Sleep Dentistry
American Sleep Dentistry: FDA-registered device maker in Cedar City, UT, United States, 2 510(k) clearances
American Sleep Dentistry is registered with the FDA (registration 3008313791) in Cedar City, UT, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 8, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008313791
- Address
- 1289 S Interstate Dr, Cedar City, UT, United States, 84720
- Owner or operator
- American Sleep Dentistry (10050648)
- Roles
- Manufacturer
- First device listed
- December 11, 2015
- Registered through
- 2026
- Brand names listed
- ASD Oral Appliance, ASD Oral Appliances, American Sleep Dentistry Oral Appliance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2017 | K163580 | ASD Oral Appliances | LRK | Substantially Equivalent | American Sleep Dentistry | accessdata.fda.gov |
| October 18, 2013 | K130504 | ASA ORAL APPLIANCES | LRK | Substantially Equivalent | American Sleep Association | accessdata.fda.gov |
Compare with other makers
Updated June 8, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.