MTML-CLEAR ALIGNER-DUAL ARCH MTML-AL-DA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for MTML-CLEAR ALIGNER-DUAL ARCH MTML-AL-DA manufactured by Dentsply Sirona Orthodontics Inc..

MAUDE Entry Details

Report Number1036212-2020-00001
MDR Report Key9827672
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-12
Date of Report2020-03-12
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-12
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
Manufacturer CountryUS
Manufacturer Phone8494424
Manufacturer G1ORTHOLAB
Manufacturer Street2525 3 MILE RD.
Manufacturer CityRACINE, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMTML-CLEAR ALIGNER-DUAL ARCH
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-03-12
Model NumberNA
Catalog NumberMTML-AL-DA
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY SIRONA ORTHODONTICS INC.
Manufacturer Address7290 26TH COURT EAST SARASOTA, FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-12

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