The following data is part of a premarket notification filed by Redent Nova Ltd with the FDA for Vatea Endontic Irrigation System.
| Device ID | K100606 |
| 510k Number | K100606 |
| Device Name: | VATEA ENDONTIC IRRIGATION SYSTEM |
| Classification | Handpiece, Air-powered, Root Canal Irrigation |
| Applicant | REDENT NOVA LTD COLUMBIA SQUARE 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan REDENT NOVA LTD COLUMBIA SQUARE 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | NYL |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-05-28 |
| Summary: | summary |