FDA applicant

Apex Dental Materials, Inc.

Lake Zurich, IL15 decisions2001–20190 recalls

FDA records 15 decisions for Apex Dental Materials, Inc. (Lake Zurich, IL) from 2001 to 2019: 15 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EBF (Material, Tooth Shade, Resin). Its devices cite 8 predicates, 1 of them its own earlier devices. 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 Apex Dental Materials, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apex Dental Materials, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Apex”

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

Apex Medical Corp. 36 Apex BioTechnology Corp. 35 Apex Medical Technologies, Inc. 8 Apex Surgical, LLC 6 Apex Metal, Inc. 3 Apex Tools & Orthopedics Co. 2 Apex Ent., Inc. 1 Apex Optical Ind. Co. 1 Apex Medical Products, LLC 1 Apex Technologies, Inc. 1 Apex Orthodontics, Inc. 1 Apex Imaging Corp. 1

Apex Dental Materials, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Apex”