FDA applicant

Prime Dental Manufacturing, Inc.

Chicago, IL9 decisions2000–20120 recalls

FDA records 9 decisions for Prime Dental Manufacturing, Inc. (Chicago, IL) from 2000 to 2012: 9 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and DYH (Adhesive, Bracket And Tooth Conditioner, 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 Prime Dental Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Prime”

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

Prime Herbs Corporation 2 Prime Pacific Health Innovations Corporation 2 Prime Medical Products, Inc. 2 Prime Horizon, Inc. 1 Prime Ideas, Inc. 1 Prime Merit Intl. Corp. 1 Prime Engineering 1

Prime Dental Manufacturing, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Prime”