Dentsply Intl.

FDA Regulatory Profile

Dentsply Intl. has 0 FDA recalls, 0 inspections, 291 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Aug 20, 2014

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances291Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K140347ANKYLOS C/X IMPLANT SYSTEMAug 20, 2014
K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMJul 23, 2013
K123615IRIS - HIGH STRENGTH GLASS CERAMICFeb 22, 2013
K103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONFeb 14, 2011
K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIOct 30, 2009
K083805ANKYLOS C/X DENTAL IMPLANT SYSTEMMay 22, 2009
K082198DURASHIELD PLUSOct 29, 2008
K072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSMar 27, 2008
K072989AXIS SYSTEMJan 28, 2008
K073117DENTIN DESENSITIZER AGENTDec 19, 2007
K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEMar 14, 2007
K070019CARRARA VOLUMIAJan 26, 2007
K062828MOUTHGUARD AND ALIGNER MATERIALSNov 27, 2006
K060836VISTADENT OC - VERSION 4Oct 27, 2006
K061427PRE-IMPRESSION CONDITIONING SOLUTIONJun 26, 2006
K053167BIOPURE MTAD ROOT CANAL CLEANSERDec 8, 2005
K053010VISTADENT AT COMPLETE, MODEL 3.1Nov 22, 2005
K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131Sep 2, 2005
K051707ECLIPSE BONDING AGENTJul 15, 2005
K051463XENO ADHESIVE WITH ACTIVATORJul 12, 2005