Atlas FDA

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

Argen Corporation · Predicate Candidate Screening

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

186 daysmedian FDA review time
280 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242458ArgenZ MTZArgen Corporation2024-10-24660
K192846Argen Clear Aligner, Argen Clear Aligner PremiumArgen Corporation2020-02-101300
K183229Argen Clear AlignerArgen Corporation2019-06-071990
K172430ArgenIS Titanium AbutmentsArgen Corporation2018-05-182800
K160248ArgenIS Titanium AbutmentsArgen Corporation2016-08-051860

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