Dentsply Intl.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
291
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K140347ANKYLOS C/X IMPLANT SYSTEMAugust 20, 2014
K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMJuly 23, 2013
K123615IRIS - HIGH STRENGTH GLASS CERAMICFebruary 22, 2013
K103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONFebruary 14, 2011
K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIOctober 30, 2009
K083805ANKYLOS C/X DENTAL IMPLANT SYSTEMMay 22, 2009
K082198DURASHIELD PLUSOctober 29, 2008
K072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSMarch 27, 2008
K072989AXIS SYSTEMJanuary 28, 2008
K073117DENTIN DESENSITIZER AGENTDecember 19, 2007
K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEMarch 14, 2007
K070019CARRARA VOLUMIAJanuary 26, 2007
K062828MOUTHGUARD AND ALIGNER MATERIALSNovember 27, 2006
K060836VISTADENT OC - VERSION 4October 27, 2006
K061427PRE-IMPRESSION CONDITIONING SOLUTIONJune 26, 2006
K053167BIOPURE MTAD ROOT CANAL CLEANSERDecember 8, 2005
K053010VISTADENT AT COMPLETE, MODEL 3.1November 22, 2005
K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131September 2, 2005
K051707ECLIPSE BONDING AGENTJuly 15, 2005
K051463XENO ADHESIVE WITH ACTIVATORJuly 12, 2005