Harry J. Bosworth Co.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Harry J. Bosworth Co.” (first 1979, latest 2011), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 10 | 10 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 8 | 8 |
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| EMA | Cement, Dental | 4 | 4 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 3 | 3 |
| EBA | Light, Surgical Headlight | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
Plus 2 more product codes.
Review panels
- Dental (44)
Most recent Harry J. Bosworth Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | EMA | 2011-03-04 | 87 |
| K100731 | BOSWORTH AIR POLISHER | EFB | 2010-12-03 | 263 |
| K061611 | BOSWORTH DENTIN RESIN | KLE | 2006-09-11 | 94 |
| K051224 | BOSWORTH SEAL | EBC | 2005-07-28 | 77 |
| K043170 | BOSWORTH BOND | KLE | 2005-02-25 | 101 |
| K040548 | AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE | DYH | 2004-03-19 | 17 |
| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | DYH | 2004-03-19 | 17 |
| K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | EBC | 2004-02-05 | 66 |
| K031439 | ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) | ELW | 2003-10-02 | 149 |
| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | EBC | 2003-09-04 | 84 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Harry J. Bosworth Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Harry A. Schlakman (2 510(k)s)
- Harry Panzer Intl. Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harry J. Bosworth Co.?
FDA lists 45 510(k) clearances under the applicant name “Harry J. Bosworth Co.” (first 1979, latest 2011), across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Harry J. Bosworth Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harry J. Bosworth Co. is 83 days.
Which FDA product codes appear under Harry J. Bosworth Co.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 10); EBI (Resin, Denture, Relining, Repairing, Rebasing, 8); EBF (Material, Tooth Shade, Resin, 6).
Next steps
- See all 45 Harry J. Bosworth Co. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Harry J. Bosworth Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.