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Essential Dental Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223340EDS Calculus Softener TURBO CRDecember 11, 2023
K202281EDS Bioceramic Sealer (Bioseal)February 12, 2021
K152691EDS Universal CementFebruary 25, 2016
K140846EDS COMBO-RINSEJuly 25, 2014
K132609EDS ULTRASONIC TIPSJanuary 22, 2014
K111541ENDO-EXPRESS (R) HANDPIECEMarch 16, 2012
K101504TI-CORE FLOWOctober 29, 2010
K072555EDTA PLUSDecember 13, 2007
K070401ENDO-CHXJuly 11, 2007
K063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEMFebruary 6, 2007
K943475ULTRA HYDROPHILIC ALGINAEAugust 12, 1994
K922250FLEXI-FLOW CEMENT WITH TITANIUMJanuary 26, 1994
K922252TI-CORE NEW & IMPROVEDJanuary 26, 1994
K922249FLEXI-FLOW CEMENT NATURALJanuary 26, 1994
K922251TI-CORE-NATURALJanuary 26, 1994
K914257DENTURE PRODUCT XJanuary 13, 1993
K896693FLEXI-CAST CROWN CORE SYSTEMFebruary 14, 1990
K843018FLEXI-POSTSeptember 27, 1984