510(k) Report

FDA applicant

Faico Medical, LLC

Boca Raton, FL3 decisions2020–20210 recalls

FDA records 3 decisions for Faico Medical, LLC (Boca Raton, FL) from 2020 to 2021: 3 510(k) clearances. Most are in product codes JEY (Plate, Bone) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 249 days from receipt to decision, against 211 for FDA’s reviews in the same codes and years. 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 Faico Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 22021: 1
2020high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Faico Medical, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JEYPlate, Bone1decision
  • NHAAbutment, Implant, Dental, Endosseous1decision
  • DZEImplant, Endosseous, Root-Form1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 249 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 211 days; 1 of its 3 were faster than that.

What has FDA decided for it lately?

  • K211871FAICO Dental Implant System and CAD/CAM AbutmentsFaico Medical, LLC · 2021
  • K191997FAICO CMF SystemFaico Medical, LLC · 2020
  • K192015Faico Dental Implant SystemFaico Medical, LLC · 2020

All 3 as Faico Medical, LLC →