Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Detax GmbH & Co. KG — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

177 daysmedian FDA review time
266 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200461Freeprint dentureDetax GmbH & Co. KG2020-11-162650
K200273FREEPRINT tempDetax GmbH & Co. KG2020-10-272660
K162654mollosil plusDetax GmbH & Co. KG2017-03-131710
K100247DETAX IMPLANTLINK SEMIDetax GmbH & Co. KG2010-07-231770
K994012TEMPOFIT, MODEL 02693Detax GmbH & Co. KG2000-02-16820

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda