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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device crown, preformed
Product CodeELZ
Regulation Number 872.3330
Device Class 1


Premarket Reviews
ManufacturerDecision
EZ-PEDO INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 6 6
2017 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 7 7
Hole In Material 1 1
Difficult to Insert 1 1
Material Perforation 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Information 1 1
No Code Available 1 1
Convulsion/Seizure 1 1
Suicidal Ideation 1 1
Metal Related Pathology 1 1
Implant Pain 1 1
Diarrhea 1 1
Pain 1 1
Vomiting 1 1
Anxiety 1 1
Depression 1 1
Weight Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business III Nov-27-2013
2 3M Company / Medical Division III Nov-26-2010
3 3M Company/3m Espe Dental Products II Aug-27-2013
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