BOSWORTH COPALIONER— 510(k) K933505

Substantially Equivalent

Harry J. Bosworth Co.

FDA 510(k) clearance K933505 for BOSWORTH COPALIONER, Substantially Equivalent on 1994-01-07. Applicant: Harry J. Bosworth Co.. Device class: 2.

Clearance details

Applicant: Harry J. Bosworth Co.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 1993-07-15
Decision date: 1994-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Harry J. Bosworth Co.

K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP2011-03-04
K100731 — BOSWORTH AIR POLISHER2010-12-03
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Recalls naming K933505

K-number listed on FDA's recall record

Z-2579-2023 — Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526Class II·Ongoing·Keystone Industries·20230721

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K933505.

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