Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005598536

FEI Number

3005598536

Entity Name

SOMNOMED INC.

City/State/Country

Plano, TX, US

Establishment Address

6513 Windcrest Dr Ste 100, Plano, TX 75024, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

SOMNOMED INC. (Owner Number: 9071127)

Owner / Operator Contact Address

6513 Windcrest Drive, Suite #100, Plano, TX 75024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SomnoDent Air+ Flex Herbst Advance Flex Herbst Advance Classic Herbst Shim Flex Herbst Telescopic Flex Herbst Shim Classic Herbst Telescopic Classic SomnoDent Herbst Advance Elite SomnoDent AVANT SomGauge Fusion Classic Fusion Flex Virtus Morning Repositioner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-07-28
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2011-07-28
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-05-21
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2019-07-15
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2019-07-15
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2015-11-05
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2014-10-29
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2026-06-15
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2015-11-11

Official Correspondent

Mary Kennell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SOMNOMED INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009440973	SomnoMed Phillipines Inc.	Makati City National Capital Region, PH
3005343849	SOMNOMED, LTD.	CROWS NEST New South Wales, AU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005598536. Last updated year: 2026. Please use registration number 3005598536 when referencing this establishment in official correspondence.