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Sun Dental Laboratories, LLC

FDA Regulatory Profile

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

Latest inspection
Apr 1, 2026 · OAI
Latest 510(k)
Dec 16, 2019

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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 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 1, 2026Saint Petersburg, FLDevicesOfficial Action Indicated (OAI)3006430881
Sep 20, 2023Saint Petersburg, FLDevicesVoluntary Action Indicated (VAI)3006430881

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
K190394SunClear Aligner systemDec 16, 2019

FDA data resources