The following data is part of a premarket notification filed by Core 3d Protech, S.l. with the FDA for Core 3d Abutment System For Digital Prosthetic Solutions.
| Device ID | K122295 |
| 510k Number | K122295 |
| Device Name: | CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CORE 3D PROTECH, S.L. POL. IND. SANTA ANNA APARTAT 20 Santpedor, ES 08251 |
| Contact | Anna Cortina |
| Correspondent | Anna Cortina CORE 3D PROTECH, S.L. POL. IND. SANTA ANNA APARTAT 20 Santpedor, ES 08251 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2013-10-24 |
| Summary: | summary |