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 Back To Search Results
Device needle, dental
Regulation Description Dental injecting needle.
Product CodeDZM
Regulation Number 872.4730
Device Class 1


Premarket Reviews
ManufacturerDecision
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 53
Slippage of device or device component 51
Detachment of device component 41
Component(s), broken 14
Detachment of device or device component 4
Material puncture 3
Device operates differently than expected 2
Use of Device Issue 2
Needle, separation 2
User used incorrect product for intended use 2
Fracture 1
Leak 1
Loose 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
No Known Device Problem 1
Bent 1
Total Device Problems 181

-
-