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

Heraeus Kulzer,GmbH — Predicate Candidate Screening

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

74 daysmedian FDA review time
244 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083652IBOND TOTAL ETCHHeraeus Kulzer,GmbH2009-01-21430
K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSHeraeus Kulzer,GmbH2008-04-21740
K073554NEUNHeraeus Kulzer,GmbH2008-02-04480
K062515RETENTION FLOW OPAQUEHeraeus Kulzer,GmbH2006-11-22860
K050085OSTEOPAL VHeraeus Kulzer,GmbH2005-09-142440
K050854PALACOS LV+GHeraeus Kulzer,GmbH2005-07-07940
K050855PALAMED GHeraeus Kulzer,GmbH2005-07-07940
K051006IBOND NEXT GENERATIONHeraeus Kulzer,GmbH2005-06-07480
K042199TRANSLUX POWER BLUEHeraeus Kulzer,GmbH2004-09-08260
K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERHeraeus Kulzer,GmbH2004-03-01620

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