EXACTA DENTAL PRODUCTS INC

Address:44780 MACOMB INDUSTRIAL DR.,CLINTON TOWNSHIP,MI,48036,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

Material, Impression (ELW) (8) Crown And Bridge, Temporary, Resin (EBG) (2)

Premarket Exempt

Clear

FRESH Bold Impression Material - 00815619020536 Catalog Number : 1-7486

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020550 Catalog Number : 1-7492

Device Description : FRESH Bold Impression Material Medium Body Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020567 Catalog Number : 1-7493

Device Description : FRESH Bold Impression Material Heavy Body Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020574 Catalog Number : 1-7494

Device Description : FRESH Bold Impression Material Clear Bite Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020581 Catalog Number : 1-7495

Device Description : FRESH Bold Impression Material Clear Liquid Putty Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020598 Catalog Number : 1-7496

Device Description : FRESH Bold Impression Material Monophase Fast Set Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020604 Catalog Number : 1-7497

Device Description : FRESH Bold Impression Material Light Body Fast Set Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619020628 Catalog Number : 1-7701-FS

Device Description : FRESH Bold Impression Material Blu Max Bite Registration Cartridge

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619020642 Catalog Number : 1-NA1-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619020659 Catalog Number : 1-NA2-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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