Company ยท US
Harry J. Bosworth Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2011. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELW | Material, Impression | 11 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 8 |
| EBF | Material, Tooth Shade, Resin | 6 |
| EMA | Cement, Dental | 4 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 |
| EBA | Light, Surgical Headlight | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EFB | Handpiece, Air-Powered, Dental | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 |
| LBH | Varnish, Cavity | 2 |
| EDI | 1 | |
| EHY | Tray, Impression, Preformed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2011 | K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP Harry J. Bosworth Co. | EMA |
| Dec 3, 2010 | K100731 | BOSWORTH AIR POLISHER Harry J. Bosworth Co. | EFB |
| Sep 11, 2006 | K061611 | BOSWORTH DENTIN RESIN Harry J. Bosworth Co. | KLE |
| Jul 28, 2005 | K051224 | BOSWORTH SEAL Harry J. Bosworth Co. | EBC |
| Feb 25, 2005 | K043170 | BOSWORTH BOND Harry J. Bosworth Co. | KLE |
| Mar 19, 2004 | K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE Harry J. Bosworth Co. | DYH |
| Mar 19, 2004 | K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE Harry J. Bosworth Co. | DYH |
| Feb 5, 2004 | K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP Harry J. Bosworth Co. | EBC |
| Oct 2, 2003 | K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) Harry J. Bosworth Co. | ELW |
| Sep 4, 2003 | K031811 | PIT & FISSURE SEALANT WITH FLUORIDE Harry J. Bosworth Co. | EBC |
| Apr 13, 2000 | K994027 | ACTIVATOR PASTE Harry J. Bosworth Co. | ELW |
| Dec 21, 1999 | K993716 | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE Harry J. Bosworth Co. | EBF |
| Dec 2, 1999 | K991492 | LC COMPOSITE Harry J. Bosworth Co. | EFB |
| Jul 26, 1999 | K991631 | FASTRAY LC Harry J. Bosworth Co. | ELW |
| Jul 15, 1999 | K991490 | ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) Harry J. Bosworth Co. | ELW |
| Jul 15, 1999 | K991489 | ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) Harry J. Bosworth Co. | ELW |
| Jun 21, 1999 | K991491 | FLC COMPOSITE Harry J. Bosworth Co. | EBF |
| Jun 21, 1999 | K991488 | SELF CURE COMPOSITE Harry J. Bosworth Co. | EBF |
| May 17, 1999 | K990699 | ORTHO-GLOW GLITTER Harry J. Bosworth Co. | EBI |
| Feb 9, 1999 | K981862 | RESIN 4 Harry J. Bosworth Co. | EBI |
| Dec 10, 1998 | K983752 | ALUMINA-ZINC OXIDE POWDERS F AND R Harry J. Bosworth Co. | EMA |
| Nov 3, 1998 | K981691 | SILICONE SOFT RELINE Harry J. Bosworth Co. | EBI |
| Oct 1, 1998 | K981861 | LINER 1:HARD RELINE LIQUID Harry J. Bosworth Co. | EBI |
| Jul 28, 1998 | K981618 | LIQUID A Harry J. Bosworth Co. | EMA |
| Jun 25, 1996 | K961199 | BOSWORTH TEMPORARY RESIN Harry J. Bosworth Co. | EBG |
| May 24, 1996 | K961198 | BOSWORTH CH I Harry J. Bosworth Co. | EBG |
| May 17, 1996 | K961201 | BOSWORTH IMPRESSION MATERIAL II Harry J. Bosworth Co. | ELW |
| May 17, 1996 | K961200 | BOSWORTH LIQUID RESIN II Harry J. Bosworth Co. | EBI |
| Feb 14, 1996 | K960063 | BOSWORTH IMPRESSION MATERIAL I Harry J. Bosworth Co. | ELW |
| Feb 16, 1995 | K946317 | HARRY J. BOSWORTH RESIN I. Harry J. Bosworth Co. | EBI |
| Mar 28, 1994 | K940402 | SUPERGEL/SUPPRESSED DUST Harry J. Bosworth Co. | ELW |
| Jan 7, 1994 | K933505 | BOSWORTH COPALIONER Harry J. Bosworth Co. | LBH |
| May 5, 1993 | K926033 | VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD Harry J. Bosworth Co. | ELW |
| Jun 1, 1988 | K881026 | CONTAC, A DENTIN SEALANT Harry J. Bosworth Co. | LBH |
| Feb 18, 1988 | K874500 | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. Harry J. Bosworth Co. | EMA |
| Sep 27, 1985 | K852868 | WUNDERSHADE Harry J. Bosworth Co. | EBF |
| Sep 27, 1984 | K842576 | CLEAR LINER Harry J. Bosworth Co. | EBI |
| Sep 27, 1984 | K842448 | BOSWORTH SUPER BOND DENTAL ADHESIVE Harry J. Bosworth Co. | DYH |
| May 22, 1984 | K841667 | WUNDERFIL Harry J. Bosworth Co. | EBF |
| May 1, 1984 | K840405 | BOSWORTH DENT-ALL Harry J. Bosworth Co. | EBI |
| May 5, 1982 | K820892 | BOSWORTH WOODEN WEDGES Harry J. Bosworth Co. | |
| Aug 20, 1981 | K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM Harry J. Bosworth Co. | EBF |
| Mar 18, 1980 | K800548 | SUPERSIL Harry J. Bosworth Co. | ELW |
| Aug 3, 1979 | K790807 | METALIT Harry J. Bosworth Co. | EBA |
| Aug 3, 1979 | K790806 | PORCELIT Harry J. Bosworth Co. | EBA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2005 | Harry J Bosworth Company Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make Terminated |
ELW | None listed |
| Jan 25, 2005 | Harry J Bosworth Company Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; c Terminated |
EHY | None listed |
| Jan 25, 2005 | Harry J Bosworth Company Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The Bosworth Company, 7227 North Hamlin Avenue, Terminated |
EDI | None listed |