The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Helioseal F Plus.
| Device ID | K190339 |
| 510k Number | K190339 |
| Device Name: | Helioseal F Plus |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | Ivoclar Vivadent, AG Bendererstrasse 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Lori Aleshin Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-07-29 |
| Summary: | summary |