The following data is part of a premarket notification filed by Itena Clinical with the FDA for Dentocore/dentocore Body.
| Device ID | K121769 |
| 510k Number | K121769 |
| Device Name: | DENTOCORE/DENTOCORE BODY |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2013-03-05 |
| Summary: | summary |