Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009440973

FEI Number

3009440973

Entity Name

SomnoMed Phillipines Inc.

City/State/Country

Makati City National Capital Region, PH

Establishment Address

Levels 1-3 Allegro Centre, 2284 Don Chino Roces Ave. Extension, Magallenes, Makati City National Capital Region 1231, PH

Establishment Type(s)

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

K130558

PMA Number

N/A

All Registered Proprietary Names

DentiTrac Virtus SomGauge SomnoDent Brux SomnoDent AVANT Herbst Advance Flex Herbst Advance Classic Herbst Shim Flex Herbst Telescopic Flex Herbst Shim Classic Herbst Telescopic Classic SomnoDent Herbst Advance Elite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLC	Sleep Appliances With Patient Monitoring	Dental	Class 2	872.5570	2015-10-26
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2026-06-15
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2015-11-05
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2012-11-07
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
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-05-21

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
3005343849	SOMNOMED, LTD.	CROWS NEST New South Wales, AU
3005598536	SOMNOMED INC.	Plano, TX, US

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
3005598536	SOMNOMED INC.	Plano, TX, US
3002912391	BRAEBON MEDICAL CORP.	KANATA Ontario, CA
3013116677	PROSOMNUS SLEEP TECHNOLOGIES	Pleasanton, CA, US
3005343849	SOMNOMED, LTD.	CROWS NEST New South Wales, AU
3008186372	GCDL, LLC	Prospect Heights, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009440973. Last updated year: 2026. Please use registration number 3009440973 when referencing this establishment in official correspondence.