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 | K161989 |
| 510k Number | K161989 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2018-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7701245783 | K161989 | 000 |
| D7701245653 | K161989 | 000 |
| D7701245643 | K161989 | 000 |
| D7701245633 | K161989 | 000 |
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| D7701245683 | K161989 | 000 |
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| D7701253763 | K161989 | 000 |
| D7701253753 | K161989 | 000 |
| D7701245803 | K161989 | 000 |