SOMNOMED, INC.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Anti-Snoring (LRK) (8) Mouthguard, Prescription (MQC) (1)

Premarket Exempt

Clear

Herbst Shim Flex - 00851826007106 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Classic Lingual-Less - 00851826007113 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Herbst Telescopic Flex - 00851826007120 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Herbst Shim Classic - 00851826007137 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SUAD Flex - 00851826007144 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SomnoDent Brux - 00851826007151 Catalog Number :

Device Description : Oral Device To Prevent Damage Due To Bruxism.

Device Class : U

Duns Number: 623527962

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

Herbst Advance Classic - 00851826007168 Catalog Number :

Device Description : Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SomnoDent ALPHA - 00851826007182 Catalog Number :

Device Description : Temporary Oral Device For The Treatment Of Obstructive Sleep Apnea.

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

SomnoDent AVANT - 00851826007199 Catalog Number :

Device Description : SomnoDent Avant kit with Large Strap Set

Device Class :

Duns Number: 623527962

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SomnoDent AVANT - 00851826007205 Catalog Number :

Device Description : SomnoDent Avant kit with Medium Strap Set

Device Class : 2

Duns Number: 623527962

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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