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 - 00810053770955 Catalog Number :

Device Description : Light Body Fast Set Yellow Cartridge

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770962 Catalog Number :

Device Description : DentMix Light Body Fast Set Yellow 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770979 Catalog Number :

Device Description : DentMix Light Body Fast Set Yellow 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770986 Catalog Number :

Device Description : DentMix Light Body Fast Set Yellow 10 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053770993 Catalog Number :

Device Description : DentMix Light Body Fast Set Yellow 24 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053771105 Catalog Number :

Device Description : Heavy Body Fast Set Pink Cartridge

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053771112 Catalog Number :

Device Description : DentMix Heavy Body Set Pink 2 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053771129 Catalog Number :

Device Description : DentMix Heavy Body Set Pink 4 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053771136 Catalog Number :

Device Description : DentMix Heavy Body Set Pink 10 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

DentMix - 00810053771143 Catalog Number :

Device Description : DentMix Heavy Body Set Pink 24 Pack

Device Class : 2

Duns Number: 784984267

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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