510(k) Report

FDA applicant

American Medical Ceramics, Inc.

Knoxville, TN11 decisions1990–19900 recalls

FDA records 11 decisions for American Medical Ceramics, Inc. (Knoxville, TN) in 1990: 11 510(k) clearances. All are in product code EKJ (Burnisher, Operative). 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 American Medical Ceramics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Ceramics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Medical Ceramics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like American Medical Ceramics, Inc.’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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