Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005343849

FEI Number

3005343849

Entity Name

SOMNOMED, LTD.

City/State/Country

CROWS NEST New South Wales, AU

Establishment Address

LEVEL 3, 20 CLARKE ST., CROWS NEST New South Wales NSW 2065, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K183443

PMA Number

N/A

All Registered Proprietary Names

SomnoDent Air+ Flex SomnoDent Brux DentiTrac Herbst Advance Flex Herbst Advance Classic Herbst Shim Flex Herbst Telescopic Flex Herbst Shim Classic Herbst Telescopic Classic SomnoDent Herbst Advance Elite Fusion Classic Fusion Flex SomnoDent Air Classic Lingual-Less Classic SomGauge SomnoDent AVANT

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
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2012-11-07
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2015-10-26
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-05-21
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2014-10-29
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2007-01-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2015-11-05
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

Official Correspondent

Mary Kennell

US Agent Details

Ioana Gabel Business: SomnoMed Email: igabel@somnomed.com Phone: (682) 5572600

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
3005598536	SOMNOMED INC.	Plano, TX, US

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 3005343849. Last updated year: 2026. Please use registration number 3005343849 when referencing this establishment in official correspondence.