Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2429849

FEI Number

2429849

Entity Name

TEMREX CORP.

City/State/Country

FREEPORT, NY, US

Establishment Address

300 Buffalo Ave, FREEPORT, NY 11520, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TEMREX CORP. (Owner Number: 2429849)

Owner / Operator Contact Address

300 BUFFALO AVE., P.O. BOX 182, Freeport, NY 11520, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K872569

PMA Number

N/A

All Registered Proprietary Names

DIAMOND POLISHING PASTE Crown Forms ZINROC SATIN POLISHING PASTE INTERVAL DOC'S BEST RED / DOC'S BEST WHITE CANAL SEALER DOC'S BEST RED COPPER CEMENT POWDER: DOC'S BEST UNIVERSAL LIQUID ZINROC ARTICULATING PAPER TEMREX CR COPALITE MAGNIFYING GLASSES MORELL CROWN REMOVER DOC'S BEST WHITE COPPER CEMENT POWDER BITE WING TABS SNAP BOND DENTIN ADHESIVE BITE WING LOOPS MATRIX BANDS INTERVAL LC Rite Bite Trays BITE RELATORS TEMREX CEMENT INTERVAL II PLUS GEL-ETCH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2008-12-17
ELZ	Crown, Preformed	Dental	Class 1	872.3330	1977-12-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-17
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2008-12-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-17
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2011-12-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-12-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-17
EFH	Paper, Articulation	Dental	Class 1	872.6140	2012-01-03
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-12-13
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2020-02-20
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2012-01-03
EIS	Remover, Crown	Dental	Class 1	872.4565	2012-01-03
EMA	Cement, Dental	Dental	Class 2	872.3275	2011-12-13
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	1977-12-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-12-13
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-01-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-12-17
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1977-12-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-12-17

Official Correspondent

ETHAN LEVANDER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TEMREX CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2429849. Last updated year: 2026. Please use registration number 2429849 when referencing this establishment in official correspondence.