Atlas FDA

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

Phoenix Dental, Inc. — Predicate Candidate Screening

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

164 daysmedian FDA review time
567 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120109SUPER SEAL TOOTH DESENSITIZERPhoenix Dental, Inc.2012-03-07540
K102821DISCOVREDPhoenix Dental, Inc.2011-03-111640
K983477SUPER SEALPhoenix Dental, Inc.1998-12-22810
K926101PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDROPhoenix Dental, Inc.1994-06-235670
K926102PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITANPhoenix Dental, Inc.1994-06-225660

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