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) (9) Cement, Dental (EMA) (1)

Premarket Exempt

Clear

Encore - 00817051020518 Catalog Number :

Device Description : Encore Catalyst composite, 25g

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020525 Catalog Number :

Device Description : Encore Base composite, 25g

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020532 Catalog Number :

Device Description : Encore White without Fluoride composite kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020549 Catalog Number :

Device Description : Encore Natural with Fluoride composite kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020556 Catalog Number :

Device Description : Encore Natural without Fluoride composite kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020563 Catalog Number :

Device Description : Encore AF White with Fluoride composite, 25g base & 25g catalyst

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020570 Catalog Number :

Device Description : Encore AF Natural with Fluoride composite, 25g base & 25g catalyst

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

NoMix - 00817051020587 Catalog Number :

Device Description : NoMix Starter Kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Encore - 00817051020594 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 - 00817051020600 Catalog Number :

Device Description : Encore DC Contrast Minimix composite, 12 pk

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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