The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Dental Implant System.
| Device ID | K083550 |
| 510k Number | K083550 |
| Device Name: | STRAUMANN DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan 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 | 2008-12-01 |
| Decision Date | 2009-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031715821 | K083550 | 000 |
| 07630031715586 | K083550 | 000 |
| 07630031715562 | K083550 | 000 |
| 07630031706485 | K083550 | 000 |
| 07630031706478 | K083550 | 000 |
| 07630031706461 | K083550 | 000 |
| 07630031706454 | K083550 | 000 |
| 07630031706447 | K083550 | 000 |
| 07630031706430 | K083550 | 000 |
| 07630031706423 | K083550 | 000 |
| 07630031706416 | K083550 | 000 |
| 07630031706409 | K083550 | 000 |
| 07630031706393 | K083550 | 000 |
| 07630031706386 | K083550 | 000 |
| 07630031700865 | K083550 | 000 |
| 07630031715609 | K083550 | 000 |
| 07630031715616 | K083550 | 000 |
| 07630031715623 | K083550 | 000 |
| 07630031715814 | K083550 | 000 |
| 07630031715807 | K083550 | 000 |
| 07630031715784 | K083550 | 000 |
| 07630031715777 | K083550 | 000 |
| 07630031715760 | K083550 | 000 |
| 07630031715746 | K083550 | 000 |
| 07630031715739 | K083550 | 000 |
| 07630031715722 | K083550 | 000 |
| 07630031715715 | K083550 | 000 |
| 07630031715708 | K083550 | 000 |
| 07630031715692 | K083550 | 000 |
| 07630031715685 | K083550 | 000 |
| 07630031715661 | K083550 | 000 |
| 07630031715647 | K083550 | 000 |
| 07630031700858 | K083550 | 000 |