The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Premium Implant Systems Shelta Implant Systems.
| Device ID | K162004 |
| 510k Number | K162004 |
| Device Name: | PREMIUM Implant Systems SHELTA Implant Systems |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-20 |
| Decision Date | 2016-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7701279473 | K162004 | 000 |
| D7701248423 | K162004 | 000 |
| D7701248433 | K162004 | 000 |
| D7701248443 | K162004 | 000 |
| D7701248453 | K162004 | 000 |
| D7701248463 | K162004 | 000 |
| D7701248473 | K162004 | 000 |
| D7701248483 | K162004 | 000 |
| D7701248493 | K162004 | 000 |
| D7701248413 | K162004 | 000 |
| D7701235203 | K162004 | 000 |
| D7701279483 | K162004 | 000 |
| D7701279493 | K162004 | 000 |
| D7701595403 | K162004 | 000 |
| D7701595413 | K162004 | 000 |
| D7701595423 | K162004 | 000 |
| D7701605173 | K162004 | 000 |
| D7701605183 | K162004 | 000 |
| D7701235193 | K162004 | 000 |
| D7701248503 | K162004 | 000 |
| D7701248513 | K162004 | 000 |
| D7701248523 | K162004 | 000 |
| D7701261183 | K162004 | 000 |
| D7701285783 | K162004 | 000 |
| D7701285793 | K162004 | 000 |
| D7701285803 | K162004 | 000 |
| D7701285813 | K162004 | 000 |
| D7701285823 | K162004 | 000 |
| D7701285833 | K162004 | 000 |
| D7701285843 | K162004 | 000 |
| D7701248623 | K162004 | 000 |
| D7701248613 | K162004 | 000 |
| D7701248533 | K162004 | 000 |
| D7701248543 | K162004 | 000 |
| D7701248553 | K162004 | 000 |
| D7701248563 | K162004 | 000 |
| D7701248573 | K162004 | 000 |
| D7701248583 | K162004 | 000 |
| D7701248593 | K162004 | 000 |
| D7701248603 | K162004 | 000 |
| D7701286113 | K162004 | 000 |