Manufacturer registered with FDA
Temrex Corp.
Freeport, NY, United States. Lists 14 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 28
- 510(k) clearances
- 21985–2012
- Markets registered in
- 646 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 6 markets
Where regulators' registries name Temrex Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Temrex Corp. | 2 clearances | 1985–2012 | Below |
| Canada | Health Canada | Registration holder | TEMREX CORPORATION | 21 | 2005–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Temrex CorporationTEMREX CORPORATION · Temrex Corp. | 12 | 1999–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TEMREX CORPORATION | 9 | 2006–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Temrex Corporation | 2 | 2018–2018 | Pure Global AI |
| Israel | AMAR | Manufacturer | Temrex Corp | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Temrex Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | CR PLUSDOC'S BEST RED COPPER CEMENT POWDER: DOC'S BEST UNIVERSAL LIQUIDDOC'S BEST WHITE COPPER CEMENT POWDERINTERVALINTERVAL II PLUSTEMREX CEMENTTEMREX CRTNE NON-EUGENOLZINROCZOE PLUS | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | GEL-ETCHGENTLE-ETCHINTERVAL LC | 2008 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | DIAMOND POLISHING PASTESATIN POLISHING PASTE | 2008 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | BITE WING LOOPSMATRIX BANDS | 2012 |
| Articulation PaperEFH · Class 1 | — | Maker | ARTICULATING PAPER | 2012 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | BITE WING TABS | 1977 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | BITE RELATORSRite Bite Trays | 1977 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | MORELL CROWN REMOVER | 2012 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | INTERFACE | 2008 |
| Preformed CrownELZ · Class 1 | — | Lister | Crown Forms | 1977 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | DOC'S BEST RED / DOC'S BEST WHITE CANAL SEALER | 2011 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | SNAP BOND DENTIN ADHESIVE | 2011 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | COPALITE | 2020 |
| Dental Stain EraserMAU · Class 1 | — | Maker | GEL-WHITE / STAR WHITE | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Temrex Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Scientific Pharmaceuticals (8), Confi-Dental Products Co. (2), Cooley & Cooley, Ltd. (1), Mirage Dental Systems (1), Coralite Dental Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Sep 2005 | K051952 | EUGENONE | Scientific Pharmaceuticals | EMA Dental Cement |
| 12 Nov 2003 | K031494 | DOC'S BEST WHITE COPPER CEMENT | Cooley & Cooley, Ltd. | EMA Dental Cement |
| 13 Dec 1993 | K934184 | FASTFIL | Scientific Pharmaceuticals | EMA Dental Cement |
| 9 Mar 1992 | K914325 | ROOT CANAL FILLING CEMENT | Confi-Dental Products Co. | KIF Root Canal Filling Resin |
| 6 Mar 1992 | K915511 | MIRAGE COMPLETE KIT AND MIRAGE ABC KIT | Mirage Dental Systems | KLE Resin Tooth Bonding Agent |
| 5 Oct 1990 | K903551 | TEMPOREX | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 27 Mar 1990 | K897130 | INTERFACE - CAVITY LINER | Scientific Pharmaceuticals | EJK Calcium Hydroxide Cavity Liner |
| 22 Feb 1990 | K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT | Confi-Dental Products Co. | EMA Dental Cement |
| 2 Dec 1988 | K884081 | INTERIM, TEMPORARY CEMENT | Scientific Pharmaceuticals | EMA Dental Cement |
| 12 Nov 1987 | K873686 | DIAMOND-LUSTER DENTAL POLISHING PASTE | Scientific Pharmaceuticals | EJR Oral Cavity Abrasive Polishing Agent |
| 21 Jul 1987 | K872569 | TEMREX ETCHING GEL | Scientific Pharmaceuticals | EBF Resin Tooth Shade Material |
| 19 Jul 1985 | K852157 | TEMREX DENTAL POLISHING PASTE | Scientific Pharmaceuticals | EJR Oral Cavity Abrasive Polishing Agent |
| 6 Jul 1982 | K821824 | TEM-STIK | Coralite Dental Products, Inc. | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TEMREX CORP.FDA reg. 2429849 | FREEPORT, NY, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2429849). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.