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

DentMix - 00810053770856 Catalog Number :

Device Description : Monophase Fast Set Purple Cartridge

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770863 Catalog Number :

Device Description : DentMix Monophase Fast Set Purple 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770870 Catalog Number :

Device Description : DentMix Monophase Fast Set Purple 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770887 Catalog Number :

Device Description : DentMix Monophase Fast Set Purple 10 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770894 Catalog Number :

Device Description : DentMix Monophase Fast Set Purple 24 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770900 Catalog Number :

Device Description : Light Body Regular Set Yellow Cartridge

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770917 Catalog Number :

Device Description : DentMix Light Body Regular Set Yellow 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770924 Catalog Number :

Device Description : DentMix 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

DentMix - 00810053770931 Catalog Number :

Device Description : DentMix Light Body Regular Set Yellow 10 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770948 Catalog Number :

Device Description : DentMix Light Body Regular Set Yellow 24 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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