TEMREX CORPORATION

TEMREX CORPORATION

Address:300 Buffalo Ave,FREEPORT,NY,11520,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

Cement, Dental (EMA) (7) Liner, Cavity, Calcium Hydroxide (EJK) (1) Material, Tooth Shade, Resin (EBF) (1) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

TEMREX LIQUID - 00850015110023 Catalog Number :

Device Description : LIQUID FOR MIXING WITH DENTAL CEMENT POWDER

Device Class : 2

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : No

Device Count : 1

TEMREX POWDER - 00850015110030 Catalog Number :

Device Description : POWDER FOR MIXING WITH CEMENT LIQUID

Device Class : 2

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : No

Device Count : 1

TEMREX CR PLUS - 00850015110047 Catalog Number :

Device Description : DENTAL CEMENT

Device Class : 1

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

TNE - 00850015110054 Catalog Number :

Device Description : Resin Based Dental Cement

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

TNE - 00850015110061 Catalog Number :

Device Description : Temporary Resin Based Dental Cement

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

TEMREX CR - 00850015110078 Catalog Number :

Device Description : DENTAL CEMENT

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : EMA

Prescription Use : No

Device Count : 1

GENTLE-ETCH - 00850015110092 Catalog Number :

Device Description : DENTAL ETCHING PREPARATORY MATERIAL

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

TEMREX LIQUID - 00850015110108 Catalog Number :

Device Description : Powder for Mixing with Dental Cement Liquid

Device Class : 2

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : No

Device Count : 1

INTERFACE WHITE - 00850015110115 Catalog Number :

Device Description : DENTAL CAVITY LINER AND BASE

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : EJK

Prescription Use : No

Device Count : 1

TEMREX POWDER - 00850015110122 Catalog Number :

Device Description : POWDER FOR MIXING WITH DENTAL CEMENT LIQUID

Device Class : 2

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMA

Prescription Use : No

Device Count : 1

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