The following data is part of a premarket notification filed by Sweden & Martina S.p.a. with the FDA for Prama White Implant Systems.
| Device ID | K180365 |
| 510k Number | K180365 |
| Device Name: | PRAMA White 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 | 2018-02-12 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7701340373 | K180365 | 000 |
| D7701513113 | K180365 | 000 |
| D7701513123 | K180365 | 000 |
| D7701513133 | K180365 | 000 |
| D7701513143 | K180365 | 000 |
| D7701513153 | K180365 | 000 |
| D7701513163 | K180365 | 000 |
| D7701513173 | K180365 | 000 |
| D7701513183 | K180365 | 000 |
| D7701513193 | K180365 | 000 |
| D7701422403 | K180365 | 000 |
| D7701422413 | K180365 | 000 |
| D7701099703 | K180365 | 000 |
| D7701284503 | K180365 | 000 |
| D7701284513 | K180365 | 000 |
| D7701284583 | K180365 | 000 |
| D7701284593 | K180365 | 000 |
| D7701340383 | K180365 | 000 |
| D7701513103 | K180365 | 000 |
| D7701513093 | K180365 | 000 |
| D7701513083 | K180365 | 000 |
| D7701340433 | K180365 | 000 |
| D7701340493 | K180365 | 000 |
| D7701340603 | K180365 | 000 |
| D7701340663 | K180365 | 000 |
| D7701524773 | K180365 | 000 |
| D7701524783 | K180365 | 000 |
| D7701827023 | K180365 | 000 |
| D7701827033 | K180365 | 000 |
| D7701827043 | K180365 | 000 |
| D7701827053 | K180365 | 000 |
| D7701827063 | K180365 | 000 |
| D7701827073 | K180365 | 000 |
| D7701591763 | K180365 | 000 |
| D7701591773 | K180365 | 000 |
| D7701513053 | K180365 | 000 |
| D7701513063 | K180365 | 000 |
| D7701513073 | K180365 | 000 |
| D7701340393 | K180365 | 000 |
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| D7701340413 | K180365 | 000 |
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| D7701340673 | K180365 | 000 |
| D7701340683 | K180365 | 000 |
| D7701340693 | K180365 | 000 |
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| D7701340713 | K180365 | 000 |
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| D7701341303 | K180365 | 000 |
| D7701341313 | K180365 | 000 |
| D7701341323 | K180365 | 000 |
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| D7701340633 | K180365 | 000 |
| D7701340623 | K180365 | 000 |
| D7701340423 | K180365 | 000 |
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| D7701340453 | K180365 | 000 |
| D7701340463 | K180365 | 000 |
| D7701340473 | K180365 | 000 |
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| D7701340523 | K180365 | 000 |
| D7701340533 | K180365 | 000 |
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| D7701340563 | K180365 | 000 |
| D7701340573 | K180365 | 000 |
| D7701340583 | K180365 | 000 |
| D7701340593 | K180365 | 000 |
| D7701340613 | K180365 | 000 |
| D7701341333 | K180365 | 000 |