The following data is part of a premarket notification filed by Talladium Espana S.l. with the FDA for Talladium International Implantology Abutments.
| Device ID | K090081 |
| 510k Number | K090081 |
| Device Name: | TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | TALLADIUM ESPANA S.L. PLAZA UTXESA 7, 5 A Lleida, ES 25002 |
| Contact | Diane Horwitz |
| Correspondent | Diane Horwitz TALLADIUM ESPANA S.L. PLAZA UTXESA 7, 5 A Lleida, ES 25002 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2010-06-22 |
| Summary: | summary |