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) (9) Crown And Bridge, Temporary, Resin (EBG) (1)

Premarket Exempt

Clear

EXACTA Cement Xtra - 00815619021175 Catalog Number : 7450

Device Description : EXACTA Cement Xtra 11g Syringe

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

FRESH Bold Impression Material - 00815619021267 Catalog Number : 7486

Device Description : FRESH Bold Impression Material Monophase

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

FRESH Bold Impression Material - 00815619021274 Catalog Number : 7486BK

Device Description : FRESH Bold Impression Material Monophase Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021298 Catalog Number : 7492

Device Description : FRESH Bold Impression Material Medium Body Fast Set

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

FRESH Bold Impression Material - 00815619021304 Catalog Number : 7492BK

Device Description : FRESH Bold Impression Material Medium Body Fast Set Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021311 Catalog Number : 7493

Device Description : FRESH Bold Impression Material Heavy Body Fast Set

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

FRESH Bold Impression Material - 00815619021328 Catalog Number : 7493BK

Device Description : FRESH Bold Impression Material Heavy Body Fast Set Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021335 Catalog Number : 7494

Device Description : FRESH Bold Impression Material Clear Bite

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

FRESH Bold Impression Material - 00815619021342 Catalog Number : 7494BK

Device Description : FRESH Bold Impression Material Clear Bite Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021359 Catalog Number : 7495

Device Description : FRESH Bold Impression Material Liquid Putty

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

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