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

Dreve Dentamid GmbH · Predicate Candidate Screening

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

259 daysmedian FDA review time
584 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250739Primeprint Direct AlignerDreve Dentamid GmbH2025-11-072410
K200580FotoDent dentureDreve Dentamid GmbH2020-11-192590
K190571StoneBite and StoneBite scanDreve Dentamid GmbH2019-11-072460
K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, DynDreve Dentamid GmbH2018-04-133180
K162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH2018-04-055840
K171729Fixtemp C&BDreve Dentamid GmbH2017-12-131840

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