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

Pentron Clinical Technologies — Predicate Candidate Screening

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

71 daysmedian FDA review time
162 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091512BUILD-IT LIGHT CUREPentron Clinical Technologies2009-10-301620
K081887LUTE-IT II VENEER CEMENT, MODEL NO6Pentron Clinical Technologies2008-08-29580
K072830RM BOND, MODEL J032Pentron Clinical Technologies2007-12-04620
K072480GENERATION 8 SE ADHESIVEPentron Clinical Technologies2007-11-21780
K072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N280Pentron Clinical Technologies2007-10-26461
K071500NANO-BOND II ADHESIVE SYSTEMPentron Clinical Technologies2007-08-10710
K060889SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SEPentron Clinical Technologies2006-10-272100
K060698CEMENT-IT ALL PURPOSE, MODEL N97Pentron Clinical Technologies2006-05-10552
K052106SIMILE FLOWPentron Clinical Technologies2005-10-31896
K052349AVANTE LED CURING UNIT, MODEL N44Pentron Clinical Technologies2005-10-21530
K023818FIBERFILL AGPPentron Clinical Technologies2003-04-031390
K023819FIBERFILL SGPPentron Clinical Technologies2003-03-261311
K022150TRIONOMERPentron Clinical Technologies2002-08-21500

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