FDA applicant

Harvest Dental Products, LLC

Brea, CA5 decisions2014–20230 recalls

FDA records 5 decisions for Harvest Dental Products, LLC (Brea, CA) from 2014 to 2023: 5 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 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 Harvest Dental Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2014high 3 (2023) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Harvest Dental Products, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Harvest Dental Products, LLC’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 “Harvest”

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

Harvest Technologies, Corp. 9 Harvest Intl. of America, Inc. 1

Harvest Dental Products, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Harvest”