Somnomed Inc

FDA Filings

This page includes the latest FDA filings for Somnomed Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Somnomed Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005343849
FEI Number3005343849
NameKien T. Nguyen
Owner & OperatorSOMNOMED INC.
Contact Address6513 Windcrest Drive Suite #100
Plano TX 75024 US
Official Correspondent
  • Michael Rutledge
  • 1-972-3773400-102
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6513 WINDCREST DR STE 100
PLANO, TX 75024 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3005598536
FEI Number3005598536
NameSOMNOMED INC.
Owner & OperatorSOMNOMED INC.
Contact Address6513 Windcrest Drive Suite #100
Plano TX 75024 US
Official Correspondent
  • Michael Rutledge
  • 1-972-3773400-102
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6513 Windcrest Dr Ste 100
Plano, TX 75024 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number3009440973
FEI Number3009440973
NameSomnoMed Phillipines Inc.
Owner & OperatorSOMNOMED INC.
Contact Address6513 Windcrest Drive Suite #100
Plano TX 75024 US
Official Correspondent
  • Michael Rutledge
  • 1-972-3773400-102
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAllegro Center, Level 3 2284 Pasong Tamo Extension
Makati City National Capital Region (Man, 1231 PH
Establishment TypeManufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2024-08-22
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SOMNOMED, INC.
 SomnoDent AVANT 2019-09-06
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent AVANT2019-07-15
SOMNOMED INC.
SomnoDent AVANT2019-07-15
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent AVANT2019-07-15
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent AVANT2019-07-15
SOMNOMED INC.
SomnoDent AVANT2019-07-15
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent AVANT2019-07-15
SomnoMed Inc.
SomnoDent Avant2019-05-08
SOMNOMED, INC.
 SomnoDent ALPHA 2018-07-06
SOMNOMED, INC.
 Herbst Advance Classic 2018-07-06
SOMNOMED, INC.
 SomnoDent Brux 2018-07-06
SOMNOMED, INC.
 SUAD Flex 2018-07-06
SOMNOMED, INC.
 Herbst Shim Classic 2018-07-06
SOMNOMED, INC.
 Herbst Telescopic Flex 2018-07-06
SOMNOMED, INC.
 Classic Lingual-Less 2018-07-06
SOMNOMED, INC.
 Herbst Shim Flex 2018-07-06
SOMNOMED, INC.
 SUAD Ultra 2018-07-06
SOMNOMED, INC.
 SUAD 2018-07-06
SOMNOMED, INC.
 Herbst Telescopic Classic 2018-07-06
SOMNOMED, INC.
 Herbst Advance Flex 2018-07-06
SOMNOMED, INC.
 Fusion Classic 2018-07-06
SOMNOMED, INC.
 Fusion Flex 2018-07-06
SOMNOMED, INC.
 Flex 2018-07-06
SOMNOMED, INC.
 Classic 2018-07-06
SOMNOMED, INC.
 SomnoDent Air+ 2018-07-06
SOMNOMED, INC.
 SomnoDent Air 2018-07-06
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent ALPHA2016-09-23
SOMNOMED INC.
SomnoDent ALPHA2016-09-23
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent ALPHA2016-09-23
SomnoMed Inc.
SomnoDent ALPHA2016-09-20
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SUAD2015-11-11
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SUAD Ultra2015-11-11
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SUAD Telescopic2015-11-11
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SUAD Flex2015-11-11
SOMNOMED INC.
SUAD2015-11-11
SOMNOMED INC.
SUAD Ultra2015-11-11
SOMNOMED INC.
SUAD Telescopic2015-11-11
SOMNOMED INC.
SUAD Flex2015-11-11
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Morning Repositioner2015-11-11
SOMNOMED INC.
Morning Repositioner2015-11-11
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomGauge2015-11-05
SOMNOMED INC.
SomGauge2015-11-05
Kien T. Nguyen [SOMNOMED INC.]
SomGauge2015-11-05
SomnoMed Phillipines Inc. [SOMNOMED INC.]
DentiTrac2015-10-26
SOMNOMED INC.
DentiTrac2015-10-26
Kien T. Nguyen [SOMNOMED INC.]
DentiTrac2015-10-26
SOMNOMED INC.
SomnoDent Classic With DentiTrac Micro-recorder, SomnoDent Flex With DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic Or Flex Retention) With DentiTrac Micro-recorder, SomnoDent G2 (Classic Or Flex Retention) With DentiTrac Micro-recorder,2015-06-18
SOMNOMED INC.
SomTabs2014-11-06
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Fusion Flex2014-10-29
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Fusion Classic2014-10-29
SOMNOMED INC.
Fusion Flex2014-10-29
SOMNOMED INC.
Fusion Classic2014-10-29
Kien T. Nguyen [SOMNOMED INC.]
Fusion Flex2014-10-29
Kien T. Nguyen [SOMNOMED INC.]
Fusion Classic2014-10-29
SOMNOMED INC.
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX2014-06-20
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent Herbst Advance Elite2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Telescopic Flex2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Telescopic Classic2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Shim Flex2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Shim Classic2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Advance Flex2013-05-21
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Herbst Advance Classic2013-05-21
SOMNOMED INC.
SomnoDent Herbst Advance Elite2013-05-21
SOMNOMED INC.
Herbst Telescopic Flex2013-05-21
SOMNOMED INC.
Herbst Telescopic Classic2013-05-21
SOMNOMED INC.
Herbst Shim Flex2013-05-21
SOMNOMED INC.
Herbst Shim Classic2013-05-21
SOMNOMED INC.
Herbst Advance Flex2013-05-21
SOMNOMED INC.
Herbst Advance Classic2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent Herbst Advance Elite2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Telescopic Flex2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Telescopic Classic2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Shim Flex2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Shim Classic2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Advance Flex2013-05-21
Kien T. Nguyen [SOMNOMED INC.]
Herbst Advance Classic2013-05-21
SOMNOMED INC.
SOMNODENT HERBST; CLASSIC, FLEX2013-05-17
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent Brux2012-11-07
SOMNOMED INC.
SomnoDent Brux2012-11-07
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent Brux2012-11-07
SOMNOMED INC.
SOMNODENT G22012-05-30
SOMNOMED INC
SOMNOBRUX SPLINTS2011-12-13
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent Air+2011-07-28
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Flex2011-07-28
SOMNOMED INC.
SomnoDent Air+2011-07-28
SOMNOMED INC.
Flex2011-07-28
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent Air+2011-07-28
Kien T. Nguyen [SOMNOMED INC.]
Flex2011-07-28
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent Air+2011-07-28
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Flex2011-07-28
SOMNOMED INC.
SomnoDent Air+2011-07-28
SOMNOMED INC.
Flex2011-07-28
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent Air+2011-07-28
Kien T. Nguyen [SOMNOMED INC.]
Flex2011-07-28
SOMNOMED INC.
PANTINO PRO POSITINER2011-03-28
SOMNOMED INC.
SOMNOMED BFLEX2008-01-30
SomnoMed Phillipines Inc. [SOMNOMED INC.]
SomnoDent Air2007-01-10
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Classic2007-01-10
SomnoMed Phillipines Inc. [SOMNOMED INC.]
Classic Lingual-Less2007-01-10
SOMNOMED INC.
SomnoDent Air2007-01-10
SOMNOMED INC.
Classic2007-01-10
SOMNOMED INC.
Classic Lingual-Less2007-01-10
Kien T. Nguyen [SOMNOMED INC.]
SomnoDent Air2007-01-10
Kien T. Nguyen [SOMNOMED INC.]
Classic2007-01-10
Kien T. Nguyen [SOMNOMED INC.]
Classic Lingual-Less2007-01-10

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code6D8J5SOMNOMED, INC.
CAGE Code6D8J5SOMNOMED, INC.
S.A.M. Registration6D8J5 [623527962]SOMNOMED, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092931630Hong Kong,Hong Kong -> Long Beach, CaliforniaBOX HS CODE:48191000 3PALLETS=116CTNS116 CTN
2020092245006Hong Kong,Hong Kong -> Long Beach, CaliforniaBOX HS CODE:48191000 3PALLETS=116CTNS116 CTN
2020091944392Hong Kong,Hong Kong -> Long Beach, CaliforniaBOX HS CODE:48191000 3PALLETS=116CTNS116 CTN
2020082728467Stadersand,Federal Republic of Germany -> Houston, TexasSOMTABS373 PKG
2020082627775Stadersand,Federal Republic of Germany -> Houston, TexasSOMTABS373 PKG
2020081865439Xiamen,China (Mainland) -> Los Angeles, CaliforniaSPC576- FUSION ADJUSTMENT KIT 15MM SPC450- BRUX TRAVEL PACK 35MM( NO MAINTENANCE KIT) 19CTNS=1PALLET "THIS SHIPMENT CONTAINS NO WOOD PACKING MATERIALS." AMS H BL NO.:XMUSDFW0G00319 CTN
2020081756827Stadersand,Federal Republic of Germany -> Houston, TexasSOMTABS4 PKG
2020042247550Xiamen,China (Mainland) -> Los Angeles, CaliforniaSPC450- BRUX TRAVEL PACK 35MM ( NO MAINTENANCE KIT) SPC445- CLASSIC FLEX TRAVEL PACK ROW (EXCLUDES BITE BLOCK) SPC503- CLASSIC FLEX TRAVEL PACK ROW (EXCLUDES BITE BLOCK) SPC576- FUSION ADJUSTMENT KIT 15MM133 CTN
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