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) (5) Crown And Bridge, Temporary, Resin (EBG) (4) Material, Tooth Shade, Resin (EBF) (1) Sealant, Pit And Fissure, And Conditioner (EBC) (1)

Premarket Exempt

Clear

FRESH Bold Impression Material - 00815619021366 Catalog Number : 7495BK

Device Description : FRESH Bold Impression Material Liquid Putty Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021373 Catalog Number : 7496

Device Description : FRESH Bold Impression Material Monophase Fast Set

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 2

FRESH Bold Impression Material - 00815619021380 Catalog Number : 7496BK

Device Description : FRESH Bold Impression Material Monophase Fast Set

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

FRESH Bold Impression Material - 00815619021397 Catalog Number : 7497

Device Description : FRESH Bold Impression Material Light 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 - 00815619021403 Catalog Number : 7497BK

Device Description : FRESH Bold Impression Material Light Body Bulk

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 24

EXACTA Flow-lc - 00815619021526 Catalog Number : 1-EFD2

Device Description : 2g syringe of flowable composite for dental restorations.

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBF, EBC

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619021809 Catalog Number : NA1-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619021816 Catalog Number : NA2-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619021823 Catalog Number : NA3-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

EXACTA Temp Xtra - 00815619021830 Catalog Number : NA3.5-FS

Device Class : 2

Duns Number: 016325552

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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