Atlas FDA

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

Merz Dental GmbH — Predicate Candidate Screening

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

80 daysmedian FDA review time
220 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173124PEEK BiosolutionMerz Dental GmbH2017-12-18800
K140758M-PM-DISC (PINK)Merz Dental GmbH2014-09-151730
K134015M-PM-DISCMerz Dental GmbH2014-04-111050
K130076PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCSMerz Dental GmbH2013-08-222200
K120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbH2012-05-211020
K080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES ANDMerz Dental GmbH2008-05-02640
K071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLOREDMerz Dental GmbH2007-08-21760
K061809ARTEGRAL IMCROWNMerz Dental GmbH2006-09-13780
K030588ARTEGRAL AND POLYSTAR SELECTIONMerz Dental GmbH2003-05-07710

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