510(k) Report

FDA applicant

Mycone Dental Supply Co., T/A Keystone Industries

Myerstown, PA1 decision2016–20160 recalls

FDA records 1 decision for Mycone Dental Supply Co., T/A Keystone Industries (Myerstown, PA) in 2016: 1 510(k) clearance. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). No 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 Mycone Dental Supply Co., T/A Keystone Industries’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Mycone Dental Supply Co., T/A Keystone Industries by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Mycone”

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