Atlas FDA

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

Dentronix, Inc. — Predicate Candidate Screening

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

21 daysmedian FDA review time
168 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910202DENTRONIX MODEL 2000Dentronix, Inc.1991-03-13620
K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.1988-07-131680
K771005NEW PODIATRY PRODUCTSDentronix, Inc.1977-06-17150
K771006MODIFIED PODIATRY PRODUCTSDentronix, Inc.1977-06-17150
K770305CUTTER, P607 BONEDentronix, Inc.1977-03-09210
K770302CUTTER, P606 BONEDentronix, Inc.1977-03-09210
K770304CUTTER, P605 GENERAL PURPOSEDentronix, Inc.1977-03-09210
K770303NIPPER, NAIL, P610 ENGLISHDentronix, Inc.1977-03-09210
K770301NIPPER, PSO4 TISSUEDentronix, Inc.1977-03-07190

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