Atlas FDA

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

Dio Department Dsi, Inc. — Predicate Candidate Screening

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

134 daysmedian FDA review time
412 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)Dio Department Dsi, Inc.2008-05-301340
K073070DIO BIOTITE-H IMPLANT SYSTEMDio Department Dsi, Inc.2008-05-161990
K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMDio Department Dsi, Inc.2008-05-141180
K070570DIO IMPLANT SYSTEMDio Department Dsi, Inc.2008-04-154120
K080126DIO PROTEM IMPLANT SYSTEMDio Department Dsi, Inc.2008-04-11850
K070569SM INTERNAL./EXTERNAL IMPLANT SYSTEMDio Department Dsi, Inc.2007-11-082530
K070568DIO PROTEM IMPLANT SYSTEMDio Department Dsi, Inc.2007-05-25860
K061797SM IMPLANT SYSTEMSDio Department Dsi, Inc.2006-09-01670

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