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) (4) Varnish, Cavity (LBH) (3) Agent, Tooth Bonding, Resin (KLE) (1) Material, Tooth Shade, Resin (EBF) (1) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

ZINROC POWDER - 00850015110238 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

ZINROC POWDER - 00850015110245 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

ZINROC POWDER - 00850015110252 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

ZINROC POWDER - 00850015110269 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

ZOE PLUS - 00850015110276 Catalog Number :

Device Description : DENTAL CEMENT

Device Class : 1

Duns Number: 012072823

Premarket Exempt : Yes

Product Code : EMB

Prescription Use : No

Device Count : 1

COPALITE - 00850015110283 Catalog Number :

Device Description : DENTAL VARNISH AND TUBULI SEAL

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1

COPALITE - 00850015110290 Catalog Number :

Device Description : DENTAL VARNISH AND TUBULI SEAL

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1

COPALITE - 00850015110306 Catalog Number :

Device Description : DENTAL VARNISH AND TUBULI SEAL

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 1

COPALITE SNAP BOND - 00850015110313 Catalog Number :

Device Description : DENTIN BONDING ADHESIVE

Device Class : 2

Duns Number: 012072823

Premarket Exempt : No

Product Code : KLE

Prescription Use : No

Device Count : 1

TEMREX GENTLE ETCH - 00850015110320 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

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