The following data is part of a premarket notification filed by Sweden & Martina S.p.a with the FDA for Premium One Implant Systems.
| Device ID | K172560 |
| 510k Number | K172560 |
| Device Name: | PREMIUM ONE Implant Systems |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Sweden & Martina S.p.A via Veneto, 10 Due Carrare, IT 35020 |
| Contact | Alessia Pezzato |
| Correspondent | Alessia Pezzato Sweden & Martina S.p.A via Veneto, 10 Due Carrare, IT 35020 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-25 |
| Decision Date | 2017-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7701304813 | K172560 | 000 |
| D7701304633 | K172560 | 000 |
| D7701304643 | K172560 | 000 |
| D7701304653 | K172560 | 000 |
| D7701304663 | K172560 | 000 |
| D7701304673 | K172560 | 000 |
| D7701304683 | K172560 | 000 |
| D7701304763 | K172560 | 000 |
| D7701304773 | K172560 | 000 |
| D7701304783 | K172560 | 000 |
| D7701304793 | K172560 | 000 |
| D7701304803 | K172560 | 000 |
| D7701304623 | K172560 | 000 |