Atlas FDA

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

Austenal, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time
173 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011674DC - CRISTALAustenal, Inc.2001-09-04970
K001799DC-TELLAustenal, Inc.2000-08-10570
K001815DC ZIRKONAustenal, Inc.2000-08-10560
K001798DC TITANAustenal, Inc.2000-07-31470
K970522MYERSON'S ECONOMY DENTURE BASE MATERIALAustenal, Inc.1997-05-14920
K970205VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROAustenal, Inc.1997-04-21900
K955509MIDAS GOLD ELECTROFORMING SYSTEMAustenal, Inc.1995-12-28240
K954810MYERSON IR DENTURE BASEAustenal, Inc.1995-11-29410
K933468MYERSON'S PERMASOFT SOFT RELINE MATERIALAustenal, Inc.1994-01-051730
K924526DENTURE PLASTIC TEETHAustenal, Inc.1992-11-04570

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