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Faico Medical, LLC

FDA Regulatory Profile

Faico Medical, LLC has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 2, 2023 · VAI
Latest 510(k)
Nov 18, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 2, 2023Boca Raton, FLDevicesVoluntary Action Indicated (VAI)3016750097

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K211871FAICO Dental Implant System and CAD/CAM AbutmentsNov 18, 2021
K191997FAICO CMF SystemApr 22, 2020
K192015Faico Dental Implant SystemApr 3, 2020

FDA data resources