HARRY J. BOSWORTH RESIN I.— 510(k) K946317

Name: FDA 510(k) clearance K946317
Creator: U.S. Food and Drug Administration
Published: 1995-02-16

Substantially Equivalent

Harry J. Bosworth Co.

FDA 510(k) clearance K946317 for HARRY J. BOSWORTH RESIN I., Substantially Equivalent on 1995-02-16. Applicant: Harry J. Bosworth Co.. Device class: 2.

Clearance details

Applicant: Harry J. Bosworth Co.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1994-12-28
Decision date: 1995-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Download summary PDF View on FDA.gov ↗

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K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP2011-03-04
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K061611 — BOSWORTH DENTIN RESIN2006-09-11
K051224 — BOSWORTH SEAL2005-07-28
K043170 — BOSWORTH BOND2005-02-25

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.