Atlas FDA

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

The Argen Corporation · Predicate Candidate Screening

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

114 daysmedian FDA review time
328 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190079ArgenZ HT+The Argen Corporation2019-04-12860
K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color ModThe Argen Corporation2019-02-081220
K143051ArgenIS Titanium AbutmentsThe Argen Corporation2015-09-163280
K150919ArgenZ Esthetic PlusThe Argen Corporation2015-07-13980
K140894ARGEN PMMAThe Argen Corporation2014-07-311140
K071410ARGEN PEARL BRAND ZIRCONIAThe Argen Corporation2007-08-15860

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