510(k) Report

FDA applicant

Harry J. Bosworth Co.

Skokie, IL45 decisions1979–20111 recall

FDA records 45 decisions for Harry J. Bosworth Co. (Skokie, IL) from 1979 to 2011: 45 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Harry J. Bosworth Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Harry J. Bosworth Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELWMaterial, Impression10decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing8decisions
  • EBFMaterial, Tooth Shade, Resin6decisions
  • EMACement, Dental4decisions
  • EBCSealant, Pit And Fissure, And Conditioner3decisions
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin3decisions

Also: KLE (2), EBG (2), EBA (2), LBH (2), EFB (2).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961199Bosworth Temporary ResinHarry J. Bosworth Co. · 19961cites it

What has FDA decided for it lately?

  • K103585Bosworth Aegis Liner & Restorative Material W/AcpHarry J. Bosworth Co. · 2011
  • K100731Bosworth Air PolisherHarry J. Bosworth Co. · 2010
  • K061611Bosworth Dentin ResinHarry J. Bosworth Co. · 2006
  • K051224Bosworth SealHarry J. Bosworth Co. · 2005
  • K043170Bosworth BondHarry J. Bosworth Co. · 2005
  • K040547Aegis Ortho Dual-Cured Orthodontic AdhesiveHarry J. Bosworth Co. · 2004
  • K040548Aegis Ortho Light-Cured Orthodontic AdhesiveHarry J. Bosworth Co. · 2004
  • K033751Aegis Pit & Fissure Sealant with AcpHarry J. Bosworth Co. · 2004

All 45 as Harry J. Bosworth Co. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K933505Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal…Jul 21, 2023Class II

Other applicant names beginning “Harry”

FDA records each applicant name separately; these may or may not be the same firm.

Harry Panzer Intl. Corp. 2Harry A. Schlakman 2