Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008313791

FEI Number

3008313791

Entity Name

AMERICAN SLEEP DENTISTRY

City/State/Country

Cedar City, UT, US

Establishment Address

1289 S Interstate Dr, Cedar City, UT 84720, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

American Sleep Dentistry (Owner Number: 10050648)

Owner / Operator Contact Address

1289 S Interstate Dr, Cedar City, UT 84720, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130504

PMA Number

N/A

All Registered Proprietary Names

ASD Oral Appliance American Sleep Dentistry Oral Appliance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-12-11

Official Correspondent

Ryan Gregerson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Sleep Dentistry

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Similar Registrations

Registration Number	Establishment Name	Location
3030914478	GELB PRACTICE	Dix Hills, NY, US
3017092365	APNOMED, INC.	Bellevue, WA, US
3039643908	EMA-SLEEP INC	Bastrop, TX, US
3007108578	TRUE FUNCTION LABORATORY INC	La Mesa, CA, US
3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008313791. Last updated year: 2026. Please use registration number 3008313791 when referencing this establishment in official correspondence.