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 pick, massaging
Regulation Description Massaging pick or tip for oral hygiene.
Product CodeJET
Regulation Number 872.6650
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 3
2022 39 39
2023 17 17
2024 12 12
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 62 63
Detachment of Device or Device Component 12 12
Material Separation 5 5
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Insufficient Information 20 20
Device Embedded In Tissue or Plaque 9 10
Foreign Body In Patient 2 2
Laceration(s) 2 2
Skin Inflammation/ Irritation 1 2
Inflammation 1 1
Tooth Fracture 1 1
Pain 1 1
Choking 1 1
Abscess 1 1
Sore Throat 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Young Dental Manufacturing I, LLC III Dec-19-2022
-
-