FDA applicant

Paragon Implant Mfg., LLC

Calabasas, CA5 decisions2025–20260 recalls

FDA records 5 decisions for Paragon Implant Mfg., LLC (Calabasas, CA) from 2025 to 2026: 5 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 158 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Paragon Implant Mfg., LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2025high 4 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Paragon Implant Mfg., LLC by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Paragon Implant Mfg., 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 “Paragon”

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

Paragon 28, Inc. 61 Paragon Vision Sciences 16 Paragon Trade Brands, Inc. 14 Paragon Diagnostics, Inc. 7 Paragon Medical 5 Paragon Optical Co. 2 Paragon Medical and Scientific, Inc. 1 Paragon Bioteck, Inc. 1

Paragon Implant Mfg., LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Paragon”