The following data is part of a premarket notification filed by 3m Company with the FDA for Lava Ultimate Cad/cam Restorative For Cerec Lava Ultimate Cad/cam Restorative For E4d Lava Ultimate Implant Crown Restor.
| Device ID | K122569 |
| 510k Number | K122569 |
| Device Name: | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR |
| Classification | Material, Tooth Shade, Resin |
| Applicant | 3M COMPANY 2510 CONWAY AVENUE St. Paul, MN 55144 |
| Contact | Ginger Cantor |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2012-09-12 |
| Summary: | summary |