FDA applicant

Alpha-Dent

Chicago, IL6 decisions1991–19940 recalls

FDA records 6 decisions for Alpha-Dent (Chicago, IL) from 1991 to 1994: 6 510(k) clearances. 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 Alpha-Dent’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alpha-Dent since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Alpha-Dent”

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

Alpha-Tec Systems, Inc. 18 Alpha Unlimited, Inc. 10 Alpha Omega Engineering, Ltd. 9 Alpha-Omega Services, Inc. 9 Alpha Therapeutic Corp. 8 Alpha Omega, Ltd. 5 Alpha Gamma Laboratory 4 Alpha-Bio Tec, Ltd. 4 Alpha Orthopaedics 3 Alpha Surgical, Inc. 2 Alpha Medical Systems 2 Alpha Dent Implants GmbH 2

Alpha-Dent

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Alpha-Dent”