FDA applicant

Smile Horizons, Inc.

Mastic Beach, NY1 decision1990–19900 recalls

FDA records 1 decision for Smile Horizons, Inc. (Mastic Beach, NY) in 1990: 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 Smile Horizons, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smile Horizons, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Smile Horizons, 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 “Smile”

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

Smile Development Corp 1

Smile Horizons, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Smile”