HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine Replacement
FDA 510(k) K100389 · Handpiece Headquarters
510(k) numberK100389
Submission
- Device name
- HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine Replacement
- Applicant
- Handpiece Headquarters
Placentia, CA, US - Received
- February 16, 2010
- Decision date
- August 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine Replacement cleared by the FDA?
HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine Replacement (K100389) received a 510(k) decision of Substantially Equivalent on August 12, 2010, 177 days after the submission was received.
What is the product code of K100389?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.