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Arcadlab

FDA Regulatory Profile

Arcadlab has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Feb 5, 2025 · NAI
Latest 510(k)
May 11, 2020

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 5, 2025West Palm Beach, FLDevicesNo Action Indicated (NAI)3014531454
Sep 1, 2023West Palm Beach, FLDevicesVoluntary Action Indicated (VAI)3014531454

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
K192244Arcad SmileStudio and Aligner SystemMay 11, 2020

FDA data resources