CENTRIX, INC.

Address:770 River Rd,SHELTON,CT,06484,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, Tooth Shade, Resin (EBF) (3) Cement, Dental (EMA) (2) Crown And Bridge, Temporary, Resin (EBG) (1) Varnish, Cavity (LBH) (1)

Premarket Exempt

Clear

Access Crown - 00817051021324 Catalog Number :

Device Description : Access Crown A3 temporary crown and bridge material, 5ml syringe

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

D/Sense - 00817051021331 Catalog Number :

Device Description : D/Sense Crystal 1ml desensitizer gel syringe, 6

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Encore - 00817051021348 Catalog Number :

Device Description : Encore DC Natural Minimix composite, 12 pk

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051021355 Catalog Number :

Device Description : Encore DC Natural with Fluoride 25ml cartridge

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051021362 Catalog Number :

Device Description : Encore DC Contrast Blue with Fluoride 25ml cartridge

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Absolute - 00817051021607 Catalog Number :

Device Description : Absolute Universal dental cement, 5ml syringe

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Absolute - 00817051021621 Catalog Number :

Device Description : Absolute Assorted 5ml dental cement syringe kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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