FAICO Dental Implant System and CAD/CAM Abutments— 510(k) K211871

Name: FDA 510(k) clearance K211871
Creator: U.S. Food and Drug Administration
Published: 2021-11-18

Substantially Equivalent

Faico Medical, LLC

FDA 510(k) clearance K211871 for FAICO Dental Implant System and CAD/CAM Abutments, Substantially Equivalent on 2021-11-18. Applicant: Faico Medical, LLC. Device class: 2.

Clearance details

Applicant: Faico Medical, LLC
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2021-06-17
Decision date: 2021-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.