DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION 623451Y-6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION 623451Y-6 manufactured by Dentsply Caulk.

MAUDE Entry Details

Report Number2515379-2019-00030
MDR Report Key9205359
Date Received2019-10-17
Date of Report2019-10-17
Date Mfgr Received2019-09-17
Date Added to Maude2019-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 W. CLARK AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION
Generic NameLINER, CAVITY, CALCIUM HYDROXIDE
Product CodeEJK
Date Received2019-10-17
Model NumberNA
Catalog Number623451Y-6
Lot Number171201
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer Address38 W. CLARK AVE. MILFORD DE 19963 US 19963


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.