The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Premium - Shelta Prosthetic Components.
| Device ID | K162028 |
| 510k Number | K162028 |
| Device Name: | PREMIUM - SHELTA Prosthetic Components |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7701306503 | K162028 | 000 |
| D7701441723 | K162028 | 000 |
| D7701441713 | K162028 | 000 |
| D7701441643 | K162028 | 000 |
| D7701441633 | K162028 | 000 |
| D7701441613 | K162028 | 000 |
| D7701441603 | K162028 | 000 |
| D7701441593 | K162028 | 000 |
| D7701441233 | K162028 | 000 |
| D7701441223 | K162028 | 000 |
| D7701441203 | K162028 | 000 |
| D7701441193 | K162028 | 000 |
| D7701441183 | K162028 | 000 |
| D7701441173 | K162028 | 000 |
| D7701441163 | K162028 | 000 |
| D7701441153 | K162028 | 000 |
| D7701441143 | K162028 | 000 |
| D7701441133 | K162028 | 000 |
| D7701096163 | K162028 | 000 |
| D7701096173 | K162028 | 000 |
| D7701107053 | K162028 | 000 |
| D7701107023 | K162028 | 000 |
| D7701096153 | K162028 | 000 |
| D7701096143 | K162028 | 000 |
| D7701096133 | K162028 | 000 |
| D7701096123 | K162028 | 000 |
| D7701096113 | K162028 | 000 |
| D7701096083 | K162028 | 000 |
| D7701096073 | K162028 | 000 |
| D7701096063 | K162028 | 000 |
| D7701096053 | K162028 | 000 |
| D7701096033 | K162028 | 000 |
| D7701096023 | K162028 | 000 |
| D7701096013 | K162028 | 000 |
| D7701096003 | K162028 | 000 |
| D7701096193 | K162028 | 000 |
| D7701096183 | K162028 | 000 |
| D7701441123 | K162028 | 000 |