The following data is part of a premarket notification filed by Sybronendo with the FDA for Endo Vac Apical Negative Pressure Irigation System.
| Device ID | K140685 |
| 510k Number | K140685 |
| Device Name: | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM |
| Classification | Handpiece, Air-powered, Root Canal Irrigation |
| Applicant | SYBRONENDO 1717 W.COLLINS AVENUE Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Courtney Clark SYBRONENDO 1717 W.COLLINS AVENUE 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 | 2014-03-18 |
| Decision Date | 2014-07-02 |