K162436 is an FDA 510(k) clearance for the EndoVac Pure. This device is classified as a Handpiece, Air-powered, Root Canal Irrigation (Class I - General Controls, product code NYL).
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on December 21, 2016, 112 days after receiving the submission on August 31, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200. To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation..
| 510(k) Number | K162436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2016 |
| Decision Date | December 21, 2016 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NYL — Handpiece, Air-powered, Root Canal Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |
| Definition | To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation. |