IPB

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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

Material, Impression (ELW) (10)

Premarket Exempt

Yes

Clear

Huggin - 00810053770757 Catalog Number :

Device Description : Light Body Fast Set Orange, 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Huggin - 00810053770764 Catalog Number :

Device Description : Heavy Body Fast Set Light Green, 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Huggin - 00810053770771 Catalog Number :

Device Description : MVP Bite Registration Material, 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Huggin - 00810053770788 Catalog Number :

Device Description : Light Body Regular Set Yellow, 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Huggin - 00810053770795 Catalog Number :

Device Description : Heavy Body Regular Set Blue, 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770801 Catalog Number :

Device Description : Monophase Regular Set Purple Cartridge

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770818 Catalog Number :

Device Description : DentMix Monophase Regular Set Purple 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770825 Catalog Number :

Device Description : DentMix Monophase Regular Set Purple 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770832 Catalog Number :

Device Description : DentMix Monophase Regular Set Purple 10 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770849 Catalog Number :

Device Description : DentMix Monophase Regular Set Purple 24 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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