Atlas FDA

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

Apex Dental Materials, Inc. · Predicate Candidate Screening

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

104 daysmedian FDA review time
206 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190998BA Pit & Fissure SealantApex Dental Materials, Inc.2019-11-082060
K161077RnD TE and RnD SEApex Dental Materials, Inc.2017-03-173330
K131043APEX UNIVERSAL ADHESIVEApex Dental Materials, Inc.2013-09-101480
K131049ZRPApex Dental Materials, Inc.2013-08-271340
K120620CLEAN AND BOOSTApex Dental Materials, Inc.2012-05-31910
K110859METAL OPAQUERApex Dental Materials, Inc.2011-06-23870
K092539SEAMFREEApex Dental Materials, Inc.2009-10-01430
K091647INJECTAFILApex Dental Materials, Inc.2009-09-211040
K062157CONFORMApex Dental Materials, Inc.2006-10-13770
K061981SURPASSApex Dental Materials, Inc.2006-07-31180
K053103INTERFACEApex Dental Materials, Inc.2006-02-01890
K020570SIMPLICITYApex Dental Materials, Inc.2002-04-24620
K010849VERTEX ETCHANTApex Dental Materials, Inc.2001-09-141770
K010547VERTEX SEALAND L/C ORTHODONTIC SEALANTApex Dental Materials, Inc.2001-08-161740
K010544VERTEX L/C ORTHODONTIC DIRECT BONDING PASTEApex Dental Materials, Inc.2001-08-101680

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