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) (8) Cement, Dental (EMA) (1) Coating, Filling Material, Resin (EBD) (1) Sealant, Pit And Fissure, And Conditioner (EBC) (1)

Premarket Exempt

Clear

Champ - 00817051020006 Catalog Number :

Device Description : Champ Pit & Fissure Sealant, 16 pk

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBD, EBC

Prescription Use : Yes

Device Count : 1

Tempit - 00817051020013 Catalog Number :

Device Description : Tempit prefilled temporary filling material tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Tempit - 00817051020020 Catalog Number :

Device Description : Tempit L/C prefilled temporary filling material tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Tempit - 00817051020037 Catalog Number :

Device Description : Tempit Ultra F prefilled temporary filling material tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Tempit - 00817051020044 Catalog Number :

Device Description : Tempit Ultra prefilled temporary filling material tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Tempit - 00817051020051 Catalog Number :

Device Description : Tempit Essentials prefilled temporary filling material tips Kit

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SuperCure - 00817051020068 Catalog Number :

Device Description : SuperCure Natural .25g prefilled tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SuperCure - 00817051020075 Catalog Number :

Device Description : SuperCure Natural .5g prefilled tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SuperCure - 00817051020082 Catalog Number :

Device Description : SuperCure Contrast .25g prefilled tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SuperCure - 00817051020099 Catalog Number :

Device Description : SuperCure Contrast .5g prefilled tips, 30

Device Class : 2

Duns Number: 053707303

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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