Not currently registered with FDA under this name
Sultan Chemists, Inc.
Englewood, NJ, United States. Named as applicant on 6 dental 510(k) clearances between 1997 and 2005. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61997–2005
- Markets registered in
- 44 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Sultan Chemists, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Sultan Chemists, Inc. | 6 clearances | 1997–2005 | Below |
| South Korea | MFDS | Manufacturer | SULTAN CHEMISTS INC | 2 | 1998–1998 | Pure Global AI |
| Israel | AMAR | Manufacturer | SULTAN CHEMISTS INC. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SULTAN CHEMISTS, INC. | 1 | 2006–2006 | 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
510(k) clearances
Clearances on which FDA names Sultan Chemists, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Nov 2005 | K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM | KLE Resin Tooth Bonding Agent |
| 20 Oct 2005 | K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL | ELW Impression Material |
| 18 Feb 2005 | K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | ELW Impression Material |
| 9 Apr 2003 | K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | ELW Impression Material |
| 15 Nov 2000 | K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | EMA Dental Cement |
| 21 Jul 1997 | K971138 | DINABASE (TM) | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (3).
Sources
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 of the most recent filing, which can be a US agent.