Harry J. Bosworth Co.
Skokie, IL, US
Harry J. Bosworth Co. appears in FDA device records in Skokie, IL. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 45 510(k) clearances for Harry J. Bosworth Co. between 1979 and 2011. The busiest year on record is 1999, with 9. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 4 |
| 1985 | 1 |
| 1988 | 2 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 5 |
| 1998 | 4 |
| 1999 | 9 |
| 2000 | 1 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | EMA | Substantially Equivalent | |
| K100731 | BOSWORTH AIR POLISHER | EFB | Substantially Equivalent | |
| K061611 | BOSWORTH DENTIN RESIN | KLE | Substantially Equivalent | |
| K051224 | BOSWORTH SEAL | EBC | Substantially Equivalent | |
| K043170 | BOSWORTH BOND | KLE | Substantially Equivalent | |
| K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | |
| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | |
| K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | EBC | Substantially Equivalent | |
| K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | ELW | Substantially Equivalent | |
| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | EBC | Substantially Equivalent | |
| K994027 | ACTIVATOR PASTE | ELW | Substantially Equivalent | |
| K993716 | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE | EBF | Substantially Equivalent | |
| K991492 | LC COMPOSITE | EFB | Substantially Equivalent | |
| K991631 | FASTRAY LC | ELW | Substantially Equivalent | |
| K991490 | ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) | ELW | Substantially Equivalent | |
| K991489 | ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) | ELW | Substantially Equivalent | |
| K991491 | FLC COMPOSITE | EBF | Substantially Equivalent | |
| K991488 | SELF CURE COMPOSITE | EBF | Substantially Equivalent | |
| K990699 | ORTHO-GLOW GLITTER | EBI | Substantially Equivalent | |
| K981862 | RESIN 4 | EBI | Substantially Equivalent | |
| K983752 | ALUMINA-ZINC OXIDE POWDERS F AND R | EMA | Substantially Equivalent | |
| K981691 | SILICONE SOFT RELINE | EBI | Substantially Equivalent | |
| K981861 | LINER 1:HARD RELINE LIQUID | EBI | Substantially Equivalent | |
| K981618 | LIQUID A | EMA | Substantially Equivalent | |
| K961199 | BOSWORTH TEMPORARY RESIN | EBG | Substantially Equivalent | |
| K961198 | BOSWORTH CH I | EBG | Substantially Equivalent | |
| K961201 | BOSWORTH IMPRESSION MATERIAL II | ELW | Substantially Equivalent | |
| K961200 | BOSWORTH LIQUID RESIN II | EBI | Substantially Equivalent | |
| K960063 | BOSWORTH IMPRESSION MATERIAL I | ELW | Substantially Equivalent | |
| K946317 | HARRY J. BOSWORTH RESIN I. | EBI | Substantially Equivalent | |
| K940402 | SUPERGEL/SUPPRESSED DUST | ELW | Substantially Equivalent | |
| K933505 | BOSWORTH COPALIONER | LBH | Substantially Equivalent | |
| K926033 | VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD | ELW | Substantially Equivalent | |
| K881026 | CONTAC, A DENTIN SEALANT | LBH | Substantially Equivalent | |
| K874500 | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. | EMA | Substantially Equivalent | |
| K852868 | WUNDERSHADE | EBF | Substantially Equivalent | |
| K842576 | CLEAR LINER | EBI | Substantially Equivalent | |
| K842448 | BOSWORTH SUPER BOND DENTAL ADHESIVE | DYH | Substantially Equivalent | |
| K841667 | WUNDERFIL | EBF | Substantially Equivalent | |
| K840405 | BOSWORTH DENT-ALL | EBI | Substantially Equivalent | |
| K820892 | BOSWORTH WOODEN WEDGES | Substantially Equivalent | ||
| K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM | EBF | Substantially Equivalent | |
| K800548 | SUPERSIL | ELW | Substantially Equivalent | |
| K790807 | METALIT | EBA | Substantially Equivalent | |
| K790806 | PORCELIT | EBA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- EFBHandpiece, Air-Powered, Dental
- EBALight, Surgical Headlight
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
- LBHVarnish, Cavity
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0421-05 | 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 the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815 | The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste. | Terminated | ||
| Z-0420-05 | 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; catalog 0921885, | The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth. | Terminated | ||
| Z-0419-05 | 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, Skokie, IL 60076-3999; catalog 092160 | The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Harry J. Bosworth Co. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain