Not currently registered with FDA under this name
Rite-Dent Manufacturing Corp.
Hialeah, FL, United States. Named as applicant on 7 dental 510(k) clearances between 2001 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 72001–2002
- Markets registered in
- 213 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Rite-Dent Manufacturing 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 | Applicant | Rite-Dent Manufacturing Corp. | 7 clearances | 2001–2002 | Below |
| South Korea | MFDS | Manufacturer | Rite Dent Manufacturing Co.Rite Dent Manufacturing Co | 13 | 2011–2011 | 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 Rite-Dent Manufacturing Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Feb 2002 | K020050 | ENAMEL BONDING SYSTEM | KLE Resin Tooth Bonding Agent |
| 7 Aug 2001 | K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 23 Jul 2001 | K011453 | TOOTH SHADE RESIN MATERIAL | EBF Resin Tooth Shade Material |
| 20 Apr 2001 | K010255 | CAVITY VARNISH | LBH Cavity Varnish |
| 27 Mar 2001 | K010240 | POLYCARBOXYLATE (PCA) CEMENT | EMA Dental Cement |
| 24 Jan 2001 | K003427 | ZINC PHOSPHATE CEMENT | EMA Dental Cement |
| 23 Jan 2001 | K003426 | ALGINATE IMPRESSION MATERIAL | ELW Impression Material |
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.