• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device handpiece, air-powered, root canal irrigation
Regulation Description Dental handpiece and accessories.
Definition To clean the root canal prior to filling and used for root canal irrigation.
Physical State It is composed or aluminum, stainless steel and plastic
Technical Method It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal
Target Area It is used to treat a tooth during a root canal procedure
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNYL
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.4200
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions
Third Party Review Not Third Party Eligible
-
-