The following data is part of a premarket notification filed by Straumann Usa with the FDA for Pure Ceramic Implants.
| Device ID | K151328 |
| 510k Number | K151328 |
| Device Name: | PURE Ceramic Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Chris Klaczyk |
| Correspondent | Nandini Murthy STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031714268 | K151328 | 000 |
| 07630031713919 | K151328 | 000 |
| 07630031713896 | K151328 | 000 |
| 07630031713872 | K151328 | 000 |
| 07630031713858 | K151328 | 000 |
| 07630031713841 | K151328 | 000 |
| 07630031713834 | K151328 | 000 |
| 07630031713827 | K151328 | 000 |
| 07630031713810 | K151328 | 000 |
| 07630031713803 | K151328 | 000 |
| 07630031713797 | K151328 | 000 |
| 07630031713933 | K151328 | 000 |
| 07630031713957 | K151328 | 000 |
| 07630031714251 | K151328 | 000 |
| 07630031714244 | K151328 | 000 |
| 07630031714237 | K151328 | 000 |
| 07630031714220 | K151328 | 000 |
| 07630031714213 | K151328 | 000 |
| 07630031714206 | K151328 | 000 |
| 07630031714190 | K151328 | 000 |
| 07630031714015 | K151328 | 000 |
| 07630031713995 | K151328 | 000 |
| 07630031713971 | K151328 | 000 |
| 07630031713780 | K151328 | 000 |