Atlas FDA

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

Dentsply Intl., Inc. · Predicate Candidate Screening

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

97 daysmedian FDA review time
190 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140347ANKYLOS C/X IMPLANT SYSTEMDentsply Intl., Inc.2014-08-201900
K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMDentsply Intl., Inc.2013-07-231170
K103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONDentsply Intl., Inc.2011-02-141040
K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIDentsply Intl., Inc.2009-10-30170
K083805ANKYLOS C/X DENTAL IMPLANT SYSTEMDentsply Intl., Inc.2009-05-221510
K082198DURASHIELD PLUSDentsply Intl., Inc.2008-10-29860
K072989AXIS SYSTEMDentsply Intl., Inc.2008-01-28970
K073117DENTIN DESENSITIZER AGENTDentsply Intl., Inc.2007-12-19440
K062828MOUTHGUARD AND ALIGNER MATERIALSDentsply Intl., Inc.2006-11-27680
K060836VISTADENT OC - VERSION 4Dentsply Intl., Inc.2006-10-272130
K053167BIOPURE MTAD ROOT CANAL CLEANSERDentsply Intl., Inc.2005-12-08240
K053010VISTADENT AT COMPLETE, MODEL 3.1Dentsply Intl., Inc.2005-11-22270

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