Dentsply Interntional

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K092614X-SMART EASYDecember 2, 2009
K092030ELATION MB METAL REINFORCED PLASTIC BRACKETJuly 24, 2009
K090454ALLURE MB CERAMIC BRACKETSMarch 20, 2009
K082973STER-MATE STERILE LAVAGE KITJanuary 29, 2009
K082974MYSTIQUE MB CERAMIC BRACKETSNovember 7, 2008
K081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSIONMay 22, 2008
K080311MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEMApril 18, 2008
K080246COMPOSITE ALIGNER BUTTONApril 11, 2008
K080203MTA ROOT CANAL SEALERMarch 26, 2008
K073173SELF-ADHESIVE RESIN CEMENTJanuary 23, 2008
K073218MTA ADVANCED MATERIALJanuary 7, 2008
K071817OSTEOGRAF/N-300September 4, 2007
K072058MODIFICATION TO: OSTEOGRAF/N-700August 3, 2007