Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device instrument, filling, plastic, dental
Product CodeEIY
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 4 4
2017 4 4
2018 5 5
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Material Separation 8 8
Material Fragmentation 2 2
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 9 9
No Information 4 4
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 1 1
Insufficient Information 1 1

-
-