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) (6) Cement, Dental (EMA) (3) Varnish, Cavity (LBH) (1)

Premarket Exempt

Clear

Fluorodose - 00817051020419 Catalog Number :

Device Description : Fluorodose Bubblegum Dealer Sample

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

NoMix - 00817051020426 Catalog Number :

Device Description : NoMix 1g temporary cement syringe, 6 pk

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Absolute - 00817051020433 Catalog Number :

Device Description : Absolute Opaque dental cement, 5ml syringe

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Absolute - 00817051020440 Catalog Number :

Device Description : Absolute Translucent dental cement, 5ml syringe

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Onyx - 00817051020457 Catalog Number :

Device Description : Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 25 syringes

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Onyx - 00817051020464 Catalog Number :

Device Description : Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 6 syringes

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Onyx - 00817051020471 Catalog Number :

Device Description : Onyx Etch 1.2ml 40% Phosphoric Acid Etching Gel, 15 syringes, 50 tips

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Onyx - 00817051020488 Catalog Number :

Device Description : Onyx Etch 1.2ml 40% Phosphoric Acid Etching gel, 15 syringes, 100 tips

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

C-R Hybrid - 00817051020495 Catalog Number :

Device Description : C-R Hybrid self-cure composite resin, 25g base, 25g catalyst

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Encore - 00817051020501 Catalog Number :

Device Description : Encore White with Fluoride composite kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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