FDA applicant

Chem-E-Dent

Norwalk, CT1 decision1987–19870 recalls

FDA records 1 decision for Chem-E-Dent (Norwalk, CT) in 1987: 1 510(k) clearance. All are in product code EBF (Material, Tooth Shade, Resin). 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 Chem-E-Dent’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chem-E-Dent since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chem-E-Dent by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chem-E-Dent’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 “Chem-E-Dent”

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

Chem-Elec, Inc. 9 Chem-Specialties Sdn Bhd 1 Chem Pharm, Inc. 1

Chem-E-Dent

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Chem-E-Dent”