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 |