The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Endovac Pure.
| Device ID | K162436 |
| 510k Number | K162436 |
| Device Name: | EndoVac Pure |
| Classification | Handpiece, Air-powered, Root Canal Irrigation |
| Applicant | Kerr Corporation 1717 W. Collins Ave Orange, CA 92867 |
| Contact | Mohammad Saad Ansari |
| Correspondent | Mohammad Saad Ansari Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Product Code | NYL |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOVAC PURE 87320119 5476505 Live/Registered |
Ormco Corporation 2017-01-31 |