Not currently registered with FDA under this name
Harry J. Bosworth Co.
Skokie, IL, United States. Named as applicant on 44 dental 510(k) clearances between 1979 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 441979–2011
- Markets registered in
- 424 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1976–2026
Registered in 4 markets
Where regulators' registries name Harry J. Bosworth Co. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Harry J. Bosworth Co. | 44 clearances | 1979–2011 | Below |
| South Korea | MFDS | Manufacturer | Harry J. Bosworth CompanyHarry J.Bosworth Company · HARRY J.BOSWORTH COMPANY | 13 | 1999–2011 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HARRY J. BOSWORTH COMPANY | 8 | 2005–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HARRY J. BOSWORTH COMPANY | 3 | 2016–2016 | 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 Harry J. Bosworth Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Mar 2011 | K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | EMA Dental Cement |
| 3 Dec 2010 | K100731 | BOSWORTH AIR POLISHER | EFB Dental Air-Powered Handpiece |
| 11 Sep 2006 | K061611 | BOSWORTH DENTIN RESIN | KLE Resin Tooth Bonding Agent |
| 28 Jul 2005 | K051224 | BOSWORTH SEAL | EBC Pit and Fissure Sealant and Conditioner |
| 25 Feb 2005 | K043170 | BOSWORTH BOND | KLE Resin Tooth Bonding Agent |
| 19 Mar 2004 | K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 19 Mar 2004 | K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 5 Feb 2004 | K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | EBC Pit and Fissure Sealant and Conditioner |
| 2 Oct 2003 | K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | ELW Impression Material |
| 4 Sep 2003 | K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | EBC Pit and Fissure Sealant and Conditioner |
| 13 Apr 2000 | K994027 | ACTIVATOR PASTE | ELW Impression Material |
| 21 Dec 1999 | K993716 | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE | EBF Resin Tooth Shade Material |
| 2 Dec 1999 | K991492 | LC COMPOSITE | EFB Dental Air-Powered Handpiece |
| 26 Jul 1999 | K991631 | FASTRAY LC | ELW Impression Material |
| 15 Jul 1999 | K991490 | ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) | ELW Impression Material |
| 15 Jul 1999 | K991489 | ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) | ELW Impression Material |
| 21 Jun 1999 | K991491 | FLC COMPOSITE | EBF Resin Tooth Shade Material |
| 21 Jun 1999 | K991488 | SELF CURE COMPOSITE | EBF Resin Tooth Shade Material |
| 17 May 1999 | K990699 | ORTHO-GLOW GLITTER | EBI Rebasing Repairing Relining Denture Resin |
| 9 Feb 1999 | K981862 | RESIN 4 | EBI Rebasing Repairing Relining Denture Resin |
| 10 Dec 1998 | K983752 | ALUMINA-ZINC OXIDE POWDERS F AND R | EMA Dental Cement |
| 3 Nov 1998 | K981691 | SILICONE SOFT RELINE | EBI Rebasing Repairing Relining Denture Resin |
| 1 Oct 1998 | K981861 | LINER 1:HARD RELINE LIQUID | EBI Rebasing Repairing Relining Denture Resin |
| 28 Jul 1998 | K981618 | LIQUID A | EMA Dental Cement |
| 25 Jun 1996 | K961199 | BOSWORTH TEMPORARY RESIN | EBG Resin Temporary Crown and Bridge |
| 24 May 1996 | K961198 | BOSWORTH CH I | EBG Resin Temporary Crown and Bridge |
| 17 May 1996 | K961201 | BOSWORTH IMPRESSION MATERIAL II | ELW Impression Material |
| 17 May 1996 | K961200 | BOSWORTH LIQUID RESIN II | EBI Rebasing Repairing Relining Denture Resin |
| 14 Feb 1996 | K960063 | BOSWORTH IMPRESSION MATERIAL I | ELW Impression Material |
| 16 Feb 1995 | K946317 | HARRY J. BOSWORTH RESIN I. | EBI Rebasing Repairing Relining Denture Resin |
| 28 Mar 1994 | K940402 | SUPERGEL/SUPPRESSED DUST | ELW Impression Material |
| 7 Jan 1994 | K933505 | BOSWORTH COPALIONER | LBH Cavity Varnish |
| 5 May 1993 | K926033 | VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD | ELW Impression Material |
| 1 Jun 1988 | K881026 | CONTAC, A DENTIN SEALANT | LBH Cavity Varnish |
| 18 Feb 1988 | K874500 | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. | EMA Dental Cement |
| 27 Sep 1985 | K852868 | WUNDERSHADE | EBF Resin Tooth Shade Material |
| 27 Sep 1984 | K842576 | CLEAR LINER | EBI Rebasing Repairing Relining Denture Resin |
| 27 Sep 1984 | K842448 | BOSWORTH SUPER BOND DENTAL ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 22 May 1984 | K841667 | WUNDERFIL | EBF Resin Tooth Shade Material |
| 1 May 1984 | K840405 | BOSWORTH DENT-ALL | EBI Rebasing Repairing Relining Denture Resin |
| 20 Aug 1981 | K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM | EBF Resin Tooth Shade Material |
| 18 Mar 1980 | K800548 | SUPERSIL | ELW Impression Material |
| 3 Aug 1979 | K790807 | METALIT | EBA Surgical Headlight Light |
| 3 Aug 1979 | K790806 | PORCELIT | EBA Surgical Headlight Light |
Some of these clearances are listed with FDA today by another company: Keystone Industries (7).
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.