Atlas FDA

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

Heraeus Kulzer, LLC — Predicate Candidate Screening

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

93 daysmedian FDA review time
120 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FASHeraeus Kulzer, LLC2013-05-17670
K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VAHeraeus Kulzer, LLC2012-12-07460
K120914FLEXITIME FAST & SCAN LIGHT FLOWHeraeus Kulzer, LLC2012-07-251200
K113574FLEXITIME MONOPHASE PRO SCANHeraeus Kulzer, LLC2012-07-132240
K112501VENUS PEARL PLT REFILL A1Heraeus Kulzer, LLC2011-12-141060
K111832PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUIDHeraeus Kulzer, LLC2011-09-29930
K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUIDHeraeus Kulzer, LLC2011-04-291130
K102770FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW,Heraeus Kulzer, LLC2010-12-21880
K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTRHeraeus Kulzer, LLC2010-09-07900
K093575GLUMA DESENSITIZER POWER GELHeraeus Kulzer, LLC2010-03-051070
K091635VENUS DIAMOND FLOWHeraeus Kulzer, LLC2009-09-03910

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