Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Dental Direkt GmbH · Predicate Candidate Screening

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

115 daysmedian FDA review time
1356 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241579DD Hybridlayer (multicolored zirconia)Dental Direkt GmbH2024-09-06950
K230410DD medical polymers (PMMA)Dental Direkt GmbH2023-06-231280
K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUTDental Direkt GmbH2023-04-25890
K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH2023-01-1113560
K193588DD ContrastDental Direkt GmbH2020-04-161150
K183569DD cube ONE MLDental Direkt GmbH2019-02-14550
K170885DD cubeX2 HSDental Direkt GmbH2017-08-011270
K153490DD medical polymersDental Direkt GmbH2016-05-131610
K150196DD cubeX2Dental Direkt GmbH2015-03-26560

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