Atlas FDA

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

Pentron Laboratory Technologies — Predicate Candidate Screening

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

61 daysmedian FDA review time
87 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023742SCULPTURE PLUS NANO-HYBRID COMPOSITEPentron Laboratory Technologies2003-01-17710
K023499GOLD CORE PLUSPentron Laboratory Technologies2003-01-13870
K023502JEWEL CAST PLUSPentron Laboratory Technologies2002-12-18610
K023501GOLD CORE 35Pentron Laboratory Technologies2002-12-18610
K020555SONATA MICRO HYBRID COMPOSITEPentron Laboratory Technologies2002-04-22610

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