Manufacturer registered with FDA

Apnomed, Inc.

Bellevue, WA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10056822Specification developer

Device types listed: 3
Brands and models: 6
510(k) clearances: 12018–2018
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Apnomed, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Orthodontic Screw Expansion RetainerDYJ · Class 1	Retainers, expanders & headgear	Maker	ApnoMed TEENApnoTx Orthodontic ApplianceDAMES Distraction Assisted Mandibular ExpanderMAPE Micro-Implant Assisted Protractor Expander	2020
Jaw Repositioning DeviceLQZ · Class 2	Anti-snoring & jaw-repositioning devices	Maker	ApnoDent appliance	2020
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	ApnoDent appliance	2020

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Apnomed, Inc. as the applicant.

Decided	510(k)	Device	Device type
21 Nov 2018	K181123	ApnoDent Appliance	LRK Anti-Snoring Device

Registered establishments

Establishment	Location	What it does
APNOMED, INC.FDA reg. 3017092365	Bellevue, WA, United States	Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10056822). 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.