The following data is part of a premarket notification filed by Novadent, Ltd. with the FDA for Perioflex Tip.
| Device ID | K923711 |
| 510k Number | K923711 |
| Device Name: | PERIOFLEX TIP |
| Classification | Unit, Oral Irrigation |
| Applicant | NOVADENT, LTD. P.O. BOX 45127 Jerusalem, IL 91450 |
| Contact | Eli M Orbach |
| Correspondent | Eli M Orbach NOVADENT, LTD. P.O. BOX 45127 Jerusalem, IL 91450 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-27 |
| Decision Date | 1994-05-16 |