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 drill, dental, intraoral
Product CodeDZA
Regulation Number 872.4130
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 9 9
2021 8 8
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Material Separation 6 6
Fracture 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Problem 2 2
Naturally Worn 1 1
Defective Device 1 1
Overheating of Device 1 1
Separation Problem 1 1
No Device Output 1 1
Temperature Problem 1 1
Detachment of Device or Device Component 1 1
Entrapment of Device 1 1
Failure to Power Up 1 1
Contamination /Decontamination Problem 1 1
Vibration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 5 5
No Information 5 5
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
Unspecified Infection 2 2
Swelling 2 2
Burn(s) 1 1
Skin Discoloration 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Blister 1 1
Partial thickness (Second Degree) Burn 1 1

-
-