510(k) K162436
K162436 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "EndoVac Pure". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code NYL (Handpiece, Air-Powered, Root Canal Irrigation), a Class I device regulated under 21 CFR 872.4200. Kerr Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2016
- Date Received
- August 31, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Root Canal Irrigation
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
To clean the root canal prior to filling and used for root canal irrigation.