The following data is part of a premarket notification filed by Itena Clinical with the FDA for Prevent Seal.
| Device ID | K122521 |
| 510k Number | K122521 |
| Device Name: | PREVENT SEAL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | ITENA CLINICAL 500 BOUL CARTIER WEST Laval, CA H7v 5b7 |
| Contact | Louis-paul Marin |
| Correspondent | Louis-paul Marin ITENA CLINICAL 500 BOUL CARTIER WEST Laval, CA H7v 5b7 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-20 |
| Decision Date | 2013-06-11 |
| Summary: | summary |