FDA applicant

Smith Companies Dental Products

Fremont, CA1 decision1996–19960 recalls

FDA records 1 decision for Smith Companies Dental Products (Fremont, CA) in 1996: 1 510(k) clearance. All are in product code EGY (Processor, Radiographic-Film, Automatic, Dental). 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, radiology panel, where it files most

How often FDA has decided Smith Companies Dental Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smith Companies Dental Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Smith Companies Dental Products’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 “Smith”

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

Smith & Nephew, Inc. 556 Smith & Nephew Richards, Inc. 88 Smith & Nephew United, Inc. 34 Smith & Nephew Medical Limited 33 Smith & Nephew Dyonics, Inc. 22 Smith & Nephew Endoscopy, Inc. 18 Smith and Nephew Donjoy, Inc. 15 Smith River Biologicals 12 Smith & Nephew, Inc., Orthopaedic Div. 10 Smith & Nephew Perry 10 Smith & Nephew Inc., Endoscopy Div. 10 Smith & Nephew, Mpl Division 9

Smith Companies Dental Products

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Smith”