Data / Medical devices / United States / Temrex Corp.

Temrex Corp.: FDA-registered device maker in Freeport, NY, United States, 14 510(k) clearances

Name: Temrex Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Temrex Corp. is registered with the FDA (registration 2429849) in Freeport, NY, United States. It lists 16 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 7, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2429849
Address: 300 Buffalo Ave, Freeport, NY, United States, 11520
Owner or operator: TEMREX CORP. (2429849)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 28, 1977
Registered through: 2026
Brand names listed: ARTICULATING PAPER, BITE RELATORS, BITE WING LOOPS, BITE WING TABS, COPALITE, CR PLUS, Crown Forms, DIAMOND POLISHING PASTE and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Specification developer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Specification developer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer, Specification developer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Repackager or relabeler	accessdata.fda.gov
Eraser, Dental Stain	MAU	1	Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Paper, Articulation	EFH	1	Specification developer	accessdata.fda.gov
Remover, Crown	EIS	1	Specification developer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Specification developer	accessdata.fda.gov
Spectacle, Magnifying	HOI	1	Specification developer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 7, 2005	K051952	EUGENONE	EMA	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
November 12, 2003	K031494	DOC'S BEST WHITE COPPER CEMENT	EMA	Substantially Equivalent	Cooley & Cooley, Ltd.	accessdata.fda.gov
December 13, 1993	K934184	FASTFIL	EMA	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
March 9, 1992	K914325	ROOT CANAL FILLING CEMENT	KIF	Substantially Equivalent	Confi-Dental Products Co.	accessdata.fda.gov
March 6, 1992	K915511	MIRAGE COMPLETE KIT AND MIRAGE ABC KIT	KLE	Substantially Equivalent	Mirage Dental Systems	accessdata.fda.gov
October 5, 1990	K903551	TEMPOREX	EBF	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
March 27, 1990	K897130	INTERFACE - CAVITY LINER	EJK	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
February 22, 1990	K896649	GRANITEC Z2, ZINC PHOSPHATE CEMENT	EMA	Substantially Equivalent	Confi-Dental Products Co.	accessdata.fda.gov
December 2, 1988	K884081	INTERIM, TEMPORARY CEMENT	EMA	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
November 12, 1987	K873686	DIAMOND-LUSTER DENTAL POLISHING PASTE	EJR	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
July 21, 1987	K872569	TEMREX ETCHING GEL	EBF	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
July 19, 1985	K852157	TEMREX DENTAL POLISHING PASTE	EJR	Substantially Equivalent	Scientific Pharmaceuticals, Inc.	accessdata.fda.gov
June 20, 1985	K851030	TEMREX-DENTIN VARNISH	LBH	Substantially Equivalent	Temrex Corp.	accessdata.fda.gov
July 6, 1982	K821824	TEM-STIK	EMA	Substantially Equivalent	Coralite Dental Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 7, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.