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Derby Dental Laboratory

FDA Regulatory Profile

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

Latest inspection
Aug 24, 2022 · NAI
Latest 510(k)
Mar 13, 2018

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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
Aug 24, 2022Louisville, KYDevicesNo Action Indicated (NAI)3006789320
Jan 16, 2020Louisville, KYDevicesNo Action Indicated (NAI)3006789320

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
K173785Custom Clear Aligner SystemMar 13, 2018

FDA data resources