Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

ELR — Predicate Candidate Screening

35 FDA 510(k) clearances under this product code; the 50 most recent screened below.

71 daysmedian FDA review time
284 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K060075FIBER-METAL POSTForemost Dental, LLC2006-03-30790
K042848FRC POSTEC PLUSIvoclar Vivadent, Inc.2004-11-22380
K030820EVERSTICK POSTStick Tech , Ltd.2003-05-20670
K020431FIBIOCOREEst. Anthogyr2002-07-031450
K012496CARBON POSTJ. Morita USA, Inc.2002-05-172870
K013802FRC POSTECIvoclar Vivadent, Inc.2002-05-011670
K012849GLASS POSTJ. Morita USA, Inc.2002-03-272360
K012354SNOWPOST, SNOWLIGHTDanville Materials, Inc.2001-10-10770
K003221HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POSTHarald Nordin S.A2000-10-2590
K003219HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POSTHarald Nordin S.A2000-10-2590
K993545TENAX WHITE POSTColtene/Whaledent, Inc.2000-04-141780
K000311PARAPOST FIBER WHITEColtene/Whaledent, Inc.2000-03-14420
K983266FIBREKOR POST SYSTEMJeneric/Pentron, Inc.1998-11-09530
K983161KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER Sabre-K , Ltd.1998-09-30210
K974649BIO-POST DENTAL POST SYSTEMAdvanced Aeromedical, Inc.1998-05-011400
K972875COSMOPOSTIvoclar North America, Inc.1997-09-17440
K945370C-POSTBisco, Inc.1995-03-311490
K950213THE STERN ROOT ANCHOR SYSTEMSterngold/Implamed1995-03-23630
K942528INTEGRAPOSTDental Logics, Inc.1994-08-05700
K942521CONSERVA POST SYSTEMBull Frog Mfg. Co.1994-07-08430
K934192PARAPOST XT SYSTEMColtene/Whaledent, Inc.1994-06-062840
K922931THERMAPOST ENDODONTIC ROOT CANAL POSTTulsa Dental Products, Ltd.1994-05-267080
K931396DENTAL SCREW POSTSHarald Nordin S.A1994-04-284050
K940680VERSADOWEL POST SYSTEMDental Power, Inc.1994-03-15330
K923232ENDODONTIC POST W/ ACCESSORIESVeillette Ent.1993-03-052470
K913019PDI PARALLEL SIDED POST KITPrecident Corp.1991-10-02850
K912720ENDO-COREMetalor Dental USA Corp.1991-08-20630
K896928FILPOSTIvoclar North America, Inc.1990-03-05840
K896693FLEXI-CAST CROWN CORE SYSTEMEssential Dental Systems, Inc.1990-02-14780
K884277AD POSTJ. Morita USA, Inc.1988-12-22710
K882125CENTRIX TRI-LAMINATE POST SYSTEMCentrix, Inc.1988-08-11830
K870130DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEMDen-Mat Corp.1987-02-19380
K851038ARCEE DENTAL POSTArcee Dental Products Co.1985-04-29460
K812092BETA POSTPaul B. Heller, D.M.D.1981-08-20280
K802515ROOT CANAL POSTUnitek Corp.1980-11-12280

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