510(k) Report

FDA applicant

Astron Dental Corp.

Wheeling, IL6 decisions1983–20110 recalls

FDA records 6 decisions for Astron Dental Corp. (Wheeling, IL) from 1983 to 2011: 6 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and JER (Cleaner, Denture, Mechanical). No recall is linked to its devices.

FDA’s records also spell it “Astron Dental Corporation”.

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 Astron Dental Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Astron Dental Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Astron Dental Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Astron”

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