Not currently registered with FDA under this name
Pascal Co., Inc.
Bellevue, WA, United States. Named as applicant on 7 dental 510(k) clearances between 1991 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 71991–2010
- Markets registered in
- 750 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Pascal Co., 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 | Pascal Co., Inc. | 7 clearances | 1991–2010 | Below |
| European Union | EUDAMED | Manufacturer | Pascal Company Inc. | 21 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Pascal Company Inc. | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Pascal Co Inc | 6 | 2009–2011 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Pascal Company Inc.Pascal Company, Inc. | 6 | 2000–2005 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PASCAL CO. INC. | 6 | 2005–2012 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PASCAL COMPANY INC. | 2 | 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 Pascal Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Oct 2010 | K102526 | BLO2X OXYGEN BLOCKER | EBF Resin Tooth Shade Material |
| 16 Mar 2009 | K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | LBH Cavity Varnish |
| 7 Jul 2004 | K040988 | ZIRCON-F PROPHYLAXIS PASTE | EJR Oral Cavity Abrasive Polishing Agent |
| 9 Jun 2004 | K040661 | RADENT PROPHY PASTE | EJR Oral Cavity Abrasive Polishing Agent |
| 2 May 2003 | K030488 | FLUORILAQ | LBH Cavity Varnish |
| 17 Jan 1992 | K912632 | OCCLUDE | EFH Articulation Paper |
| 6 Jun 1991 | K911259 | HYDENT | EFH Articulation Paper |
Some of these clearances are listed with FDA today by another company: Pascal International (1).
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.