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Detax GmbH & Co. KG

FDA Regulatory Profile

Detax GmbH & Co. KG has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 6, 2018 · VAI
Latest 510(k)
Nov 16, 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) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 6, 2018Ettlingen, GermanyDevicesVoluntary Action Indicated (VAI)1000293792

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
K200461Freeprint dentureNov 16, 2020
K200273FREEPRINT tempOct 27, 2020
K162654mollosil plusMar 13, 2017
K100247DETAX IMPLANTLINK SEMIJul 23, 2010
K994012TEMPOFIT, MODEL 02693Feb 16, 2000

FDA data resources